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Product Compliance Specialist
Iazuqy Fa Ocs Oraclecloud Com CX 1 · United States; ZSFG Building 1 - FL 02 - RM 248, San Francisco, CA, US · Active · Oracle Recruiting Cloud / Fusion HCM
Job facts
| Field | Value |
|---|---|
| Company | Iazuqy Fa Ocs Oraclecloud Com CX 1 |
| Title | Product Compliance Specialist |
| Normalized title | - |
| Department / team | Research Administration |
| Location | United States |
| Work model | - |
| Employment type | Full Time |
| Salary | - |
| Status | active |
| ATS provider | Oracle Recruiting Cloud / Fusion HCM |
| Posted / first seen | 2026-05-28 / 2026-05-31 |
| Changed / last seen | 2026-06-06 / 2026-06-06 |
Related slices
| Page | What it contains | Open |
|---|---|---|
| Company jobs | Active postings from Iazuqy Fa Ocs Oraclecloud Com CX 1. | Open |
| Company breakdowns | Role, location, ATS, and work model facets for this company. | Open |
| ATS provider jobs | Active postings observed through Oracle Recruiting Cloud / Fusion HCM. | Open |
| Provider filtered search | The same provider as a filtered job collection. | Open |
| Department jobs | Active postings in Research Administration. | Open |
| Lifecycle events | Open, update, close, and reopen events for this posting. | Open |
| Original posting | Canonical source or apply URL captured from the ATS. | Open |
Linked records
| Company | Iazuqy Fa Ocs Oraclecloud Com CX 1 |
| Source | 1ec01ec1-9ec0-4ca7-9242-3de42049e519 |
| ATS provider | Oracle Recruiting Cloud / Fusion HCM |
Description
Description
Job Function Summary:
Involves staffing, administering or managing research oversight and compliance committee activities related to research activities such as human subjects, animal use and care, conflict of interest and export control. Reviews research protocols for use in specific fields, assists in writing and reviewing protocols, and compliance with federal, state, and University mandated laws, regulations and policies.
Generic Scope
Technical leader with a high degree of knowledge in the overall field and recognized expertise in specific areas; problem-solving frequently requires analysis of unique issues / problems without precedent and / or structure. May manage programs that include formulating strategies and administering policies, processes, and resources; functions with a high degree of autonomy.
Custom Scope
The Product Compliance Professional will represent the Regulatory Sponsor (UCSF) and provide strategic oversight of contract manufacturing organizations (CMOs) supporting a complex, double-blinded, randomized, multi-site adaptive platform trial evaluating multiple investigational agents in parallel. This role serves as the lead for cGMP compliance, Quality Assurance (QA), and Chemistry, Manufacturing, and Controls (CMC) regulatory oversight on behalf of UCSF.
The position is responsible for comprehensive review and oversight of all CMO deliverables to ensure compliance with contractual Statements of Work and applicable regulatory standards, as well as coordination of clinical supply production across multiple manufacturing campaigns. The individual will oversee investigational product forecasting and supply planning, manage technical risk, interpret and resolve manufacturing and quality issues, and provide strategic recommendations prior to submission of materials to the study funder, the U.S. Department of Defense. The role requires ongoing cross-functional engagement with CMO manufacturing and IRT teams, the Regulatory Sponsor, and federal stakeholders to ensure alignment, quality, and timely execution.
Responsibilities
% of time Essential Function (Yes/No) Key Responsibilities (To be completed by Supervisor) 25% Yes Lead and coordinate cross-functional teams to ensure the CMO’s seamless product development
Expanded Responsibilities:
Serve as the primary CMC lead interfacing with the CMO’s internal functional groups (Manufacturing, MSAT, Quality, Regulatory Affairs, Supply Chain, Analytical Development, Validation) and external partners/sponsors.
Drive alignment across technical teams to ensure process development, scale-up, validation, and commercial readiness milestones are met.
Identify cross-functional risks and proactively implement mitigation strategies.
Ensure clear communication of technical updates, risks, and key decisions to senior leadership and external stakeholders.
Promote adherence to cGMP standards and company quality systems across all functional areas
25% Yes Manage the CMO’s project timelines and budgets related to CMC activities.
Expanded Responsibilities:
Develop and maintain detailed CMC project timelines spanning development, validation, regulatory submission, and lifecycle management phases.
Track progress against key milestones including:
Process development
Method development and validation
Engineering and process validation batches
Stability studies
Regulatory submission deadlines
Monitor and manage CMC budgets, including:
Manufacturing campaign costs
Analytical testing costs
Validation expenses
External vendor/CMO services
25% Yes Oversight of the CMO’s deliverables related to ensure all aspects of manufacturing, testing, and analytical development meet stringent regulatory requirements.
Expanded Responsibilities:
Ensure all CMC activities comply with global regulatory standards including FDA, EMA, ICH, and other applicable authorities.
Oversee:
Process development and scale-up activities
Analytical method development, qualification, and validation
Process validation and continued process verification
Stability program design and monitoring
Review and approve key technical documentation including:
Batch records
Validation protocols and reports
Analytical methods and specifications
Change controls and deviation investigations
Ensure manufacturing processes adhere to cGMP requirements and data integrity standards.
25% Yes Initiates and designs the development and revision of operating procedures, policies, Oversight of the CMO’s deliverables related to develop and submit CMC sections of regulatory dossiers to agencies like the FDA and EMA.
Expanded Responsibilities:
Lead the preparation, review, and finalization of CMC sections for regulatory submissions, such as INDs
Coordinate compilation of manufacturing, analytical, validation, and stability data for submission.
Ensure consistency between Quality Overall Summary (QOS) and detailed technical sections.
Collaborate with Regulatory Affairs to address agency queries, deficiency letters, and information requests.
Support preparation of responses to FDA/EMA questions within required timelines.
Ensure lifecycle management updates (e.g., process changes, site changes, specification updates) are accurately reflected in post-approval submissions.
Maintain regulatory intelligence awareness to anticipate evolving CMC requirements.
Qualifications
Required Qualifications
Bachelor’s degree in related areas 5 years of related experience Demonstrated self-discipline and independent judgment completing highly complex, broadly defined assignments Advanced knowledge and ability to apply all relevant Federal, state, and university regulations policies, and federal guidance documents Advanced knowledge of quantitative and qualitative research design, scientific research concepts and terminology Strong scientific knowledge in areas like analytical development and process development Excellent project management skills, including planning, execution, and risk management Proficiency in communicating complex scientific data to technical and non-technical audiences Deep understanding of regulatory requirements and GMP principles Strong proficiency in public speaking, and writing
Preferred Qualifications
Master's degree or PhD in related area and / or equivalent experience and training. Relevant compliance certification (if applicable) preferred.
Full job record
| Job ID | 70fc071cc47fecbca3b50ca41c7b3c6815fc214d |
| Org ID | b73f2bf1-b0ab-47ed-8db1-1f14a038aa7c |
| Source ID | 1ec01ec1-9ec0-4ca7-9242-3de42049e519 |
| Board ID | 1ec01ec1-9ec0-4ca7-9242-3de42049e519 |
| Provider | oracle_hcm |
| Provider Job Key | 2354 |
| Title | Product Compliance Specialist |
| Normalized Title | — |
| Status | active |
| Active | yes |
| Location Text | United States; ZSFG Building 1 - FL 02 - RM 248, San Francisco, CA, US |
| Department | Research Administration |
| Team | — |
| Employment Type | full_time |
| Workplace Type | — |
| Remote Policy | — |
| Country | United States |
| Region | — |
| City | — |
| Salary Raw | Description Job Function Summary: Involves staffing, administering or managing research oversight and compliance committee activities related to research activities such as human subjects, animal use and care, conflict of interest and export control. Reviews research protocols for use in specific fields, assists in writing and reviewing protocols, and compliance with federal, state, and University mandated laws, regulations and policies. Generic Scope Technical leader with a high degree of knowledge in the overall field and recognized expertise in specific areas; problem-solving frequently requires analysis of unique issues / problems without precedent and / or structure. May manage programs that include formulating strategies and administering policies, processes, and resources; functions with a high degree of autonomy. Custom Scope The Product Compliance Professional will represent the Regulatory Sponsor (UCSF) and provide strategic oversight of contract manufacturing organizations (CMOs) supporting a complex, double-blinded, randomized, multi-site adaptive platform trial evaluating multiple investigational agents in parallel. This role serves as the lead for cGMP compliance, Quality Assurance (QA), and Chemistry, Manufacturing, and Controls (CMC) regulatory oversight on behalf of UCSF. The position is responsible for comprehensive review and oversight of all CMO deliverables to ensure compliance with contractual Statements of Work and applicable regulatory standards, as well as coordination of clinical supply production across multiple manufacturing campaigns. The individual will oversee investigational product forecasting and supply planning, manage technical risk, interpret and resolve manufacturing and quality issues, and provide strategic recommendations prior to submission of materials to the study funder, the U.S. Department of Defense. The role requires ongoing cross-functional engagement with CMO manufacturing and IRT teams, the Regulatory Sponsor, and federal stakeholders to ensure alignment, quality, and timely execution. Responsibilities % of time Essential Function (Yes/No) Key Responsibilities (To be completed by Supervisor) 25% Yes Lead and coordinate cross-functional teams to ensure the CMO’s seamless product development Expanded Responsibilities: Serve as the primary CMC lead interfacing with the CMO’s internal functional groups (Manufacturing, MSAT, Quality, Regulatory Affairs, Supply Chain, Analytical Development, Validation) and external partners/sponsors. Drive alignment across technical teams to ensure process development, scale-up, validation, and commercial readiness milestones are met. Identify cross-functional risks and proactively implement mitigation strategies. Ensure clear communication of technical updates, risks, and key decisions to senior leadership and external stakeholders. Promote adherence to cGMP standards and company quality systems across all functional areas 25% Yes Manage the CMO’s project timelines and budgets related to CMC activities. Expanded Responsibilities: Develop and maintain detailed CMC project timelines spanning development, validation, regulatory submission, and lifecycle management phases. Track progress against key milestones including: Process development Method development and validation Engineering and process validation batches Stability studies Regulatory submission deadlines Monitor and manage CMC budgets, including: Manufacturing campaign costs Analytical testing costs Validation expenses External vendor/CMO services 25% Yes Oversight of the CMO’s deliverables related to ensure all aspects of manufacturing, testing, and analytical development meet stringent regulatory requirements. Expanded Responsibilities: Ensure all CMC activities comply with global regulatory standards including FDA, EMA, ICH, and other applicable authorities. Oversee: Process development and scale-up activities Analytical method development, qualification, and validation Process validation and continued process verification Stability program design and monitoring Review and approve key technical documentation including: Batch records Validation protocols and reports Analytical methods and specifications Change controls and deviation investigations Ensure manufacturing processes adhere to cGMP requirements and data integrity standards. 25% Yes Initiates and designs the development and revision of operating procedures, policies, Oversight of the CMO’s deliverables related to develop and submit CMC sections of regulatory dossiers to agencies like the FDA and EMA. Expanded Responsibilities: Lead the preparation, review, and finalization of CMC sections for regulatory submissions, such as INDs Coordinate compilation of manufacturing, analytical, validation, and stability data for submission. Ensure consistency between Quality Overall Summary (QOS) and detailed technical sections. Collaborate with Regulatory Affairs to address agency queries, deficiency letters, and information requests. Support preparation of responses to FDA/EMA questions within required timelines. Ensure lifecycle management updates (e.g., process changes, site changes, specification updates) are accurately reflected in post-approval submissions. Maintain regulatory intelligence awareness to anticipate evolving CMC requirements. Qualifications Required Qualifications Bachelor’s degree in related areas 5 years of related experience Demonstrated self-discipline and independent judgment completing highly complex, broadly defined assignments Advanced knowledge and ability to apply all relevant Federal, state, and university regulations policies, and federal guidance documents Advanced knowledge of quantitative and qualitative research design, scientific research concepts and terminology Strong scientific knowledge in areas like analytical development and process development Excellent project management skills, including planning, execution, and risk management Proficiency in communicating complex scientific data to technical and non-technical audiences Deep understanding of regulatory requirements and GMP principles Strong proficiency in public speaking, and writing Preferred Qualifications Master's degree or PhD in related area and / or equivalent experience and training. Relevant compliance certification (if applicable) preferred. |
| Salary Min | — |
| Salary Max | — |
| Salary Currency | — |
| Salary Period | — |
| Source URL | https://iazuqy.fa.ocs.oraclecloud.com/hcmUI/CandidateExperience/en/sites/CX_1/job/2354 |
| Apply URL | https://iazuqy.fa.ocs.oraclecloud.com/hcmUI/CandidateExperience/en/sites/CX_1/job/2354 |
| First Seen At | 2026-05-31 17:57:33Z |
| Last Seen At | 2026-06-06 19:36:14Z |
| Last Checked At | 2026-06-06 19:36:14Z |
| Last Changed At | 2026-06-06 11:18:11Z |
| Inactive At | — |
| Source Posted At | 2026-05-28 00:00:00Z |
| Source Updated At | — |
| Raw Payload Uri | s3://job-postings-prod-raw-590183727216/raw/provider=oracle_hcm/board=iazuqy.fa.ocs.oraclecloud.com|CX_1/date=2026-06-06/2026-06-06T19-34-57-721Z-59ddc5abcdf6a871a8f8be65341758988893a47757f1c9e6ac5fa33dd96c8fbc.json |
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font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Track progress against key milestones including:</span></span></p></li><li><p><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Process development</span></span></p><ul style=\"list-style-type: circle; padding-left: 48px;\"><li><p><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Method development and validation</span></span></p></li><li><p><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Engineering and process validation batches</span></span></p></li><li><p><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Stability studies</span></span></p></li><li><p><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Regulatory submission deadlines</span></span></p></li></ul></li><li><p><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Monitor and manage CMC budgets, including:</span></span></p><ul style=\"list-style-type: circle; padding-left: 48px;\"><li><p><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Manufacturing campaign costs</span></span></p></li><li><p><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Analytical testing costs</span></span></p></li><li><p><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Validation expenses</span></span></p></li><li><p><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">External vendor/CMO services</span></span></p></li></ul></li></ul></td></tr><tr><td>25%</td><td>Yes</td><td><p><span>Oversight of the CMO’s deliverables related to ensure all aspects of manufacturing, testing, and analytical development meet stringent regulatory requirements. </span></p><p> </p><p><span style=\"color: black;\">Expanded Responsibilities:</span></p><ul style=\"list-style-type: disc; padding-left: 48px;\"><li><p><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Ensure all CMC activities comply with global regulatory standards including FDA, EMA, ICH, and other applicable authorities.</span></span></p></li><li><p><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Oversee:</span></span></p><ul style=\"list-style-type: circle; padding-left: 48px;\"><li><p><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Process development and scale-up activities</span></span></p></li><li><p><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Analytical method development, qualification, and validation</span></span></p></li><li><p><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Process validation and continued process verification</span></span></p></li><li><p><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Stability program design and monitoring</span></span></p></li></ul></li><li><p><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Review and approve key technical documentation including:</span></span></p><ul style=\"list-style-type: circle; padding-left: 48px;\"><li><p><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Batch records</span></span></p></li><li><p><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Validation protocols and reports</span></span></p></li><li><p><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Analytical methods and specifications</span></span></p></li><li><p><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Change controls and deviation investigations</span></span></p></li></ul></li><li><p><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Ensure manufacturing processes adhere to cGMP requirements and data integrity standards.</span></span></p></li></ul></td></tr><tr><td>25%</td><td>Yes</td><td><p>Initiates and designs the development and revision of operating procedures, policies,<span>Oversight of the CMO’s deliverables related to develop and submit CMC sections of regulatory dossiers to agencies like the FDA and EMA. </span></p><p> </p><p><span style=\"color: black;\">Expanded Responsibilities:</span></p><ul style=\"list-style-type: disc; padding-left: 48px;\"><li><p><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Lead the preparation, review, and finalization of CMC sections for regulatory submissions, such as INDs</span></span></p></li><li><p><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Coordinate compilation of manufacturing, analytical, validation, and stability data for submission.</span></span></p></li><li><p><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Ensure consistency between Quality Overall Summary (QOS) and detailed technical sections.</span></span></p></li><li><p><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Collaborate with Regulatory Affairs to address agency queries, deficiency letters, and information requests.</span></span></p></li><li><p><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Support preparation of responses to FDA/EMA questions within required timelines.</span></span></p></li><li><p><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Ensure lifecycle management updates (e.g., process changes, site changes, specification updates) are accurately reflected in post-approval submissions.</span></span></p></li><li><p><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Maintain regulatory intelligence awareness to anticipate evolving CMC requirements.</span></span></p></li></ul></td></tr><tr><td> </td><td> </td><td> </td></tr><tr><td> </td><td> </td><td> </td></tr><tr><td> </td><td> </td><td> </td></tr><tr><td> </td><td> </td><td> </td></tr><tr><td> </td><td> </td><td> </td></tr><tr><td> </td><td> </td><td> </td></tr></tbody></table></figure>",
"InternalResponsibilitiesStr": "<figure class=\"table\"><table border=\"1\"><thead><tr><th>% of time</th><th>Essential Function (Yes/No)</th><th>Key Responsibilities (To be completed by Supervisor)</th></tr></thead><tbody><tr><td>25%</td><td>Yes</td><td width=\"536\" valign=\"top\" style=\"border: 1pt dotted windowtext; height: 28.7pt; padding: 0in 5.4pt; width: 402.2pt;\"><p><span>Lead and coordinate cross-functional teams to ensure the CMO’s seamless product development</span></p><p> </p><p><span style=\"color: black;\">Expanded Responsibilities:</span></p><ul style=\"list-style-type: disc; padding-left: 48px;\"><li><p><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Serve as the primary CMC lead interfacing with the CMO’s internal functional groups (Manufacturing, MSAT, Quality, Regulatory Affairs, Supply Chain, Analytical Development, Validation) and external partners/sponsors.</span></span></p></li><li><p><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Drive alignment across technical teams to ensure process development, scale-up, validation, and commercial readiness milestones are met.</span></span></p></li><li><p><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Identify cross-functional risks and proactively implement mitigation strategies.</span></span></p></li><li><p><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Ensure clear communication of technical updates, risks, and key decisions to senior leadership and external stakeholders.</span></span></p></li><li><p><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Promote adherence to cGMP standards and company quality systems across all functional areas</span></span></p></li></ul></td></tr><tr><td>25%</td><td>Yes</td><td><p><span>Manage the CMO’s project timelines and budgets related to CMC activities. </span></p><p> </p><p><span style=\"color: black;\">Expanded Responsibilities:</span></p><ul style=\"list-style-type: disc; padding-left: 48px;\"><li><p><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Develop and maintain detailed CMC project timelines spanning development, validation, regulatory submission, and lifecycle management phases.</span></span></p></li><li><p><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Track progress against key milestones including:</span></span></p></li><li><p><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Process development</span></span></p><ul style=\"list-style-type: circle; padding-left: 48px;\"><li><p><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Method development and validation</span></span></p></li><li><p><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Engineering and process validation batches</span></span></p></li><li><p><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Stability studies</span></span></p></li><li><p><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Regulatory submission deadlines</span></span></p></li></ul></li><li><p><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Monitor and manage CMC budgets, including:</span></span></p><ul style=\"list-style-type: circle; padding-left: 48px;\"><li><p><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Manufacturing campaign costs</span></span></p></li><li><p><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Analytical testing costs</span></span></p></li><li><p><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Validation expenses</span></span></p></li><li><p><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">External vendor/CMO services</span></span></p></li></ul></li></ul></td></tr><tr><td>25%</td><td>Yes</td><td><p><span>Oversight of the CMO’s deliverables related to ensure all aspects of manufacturing, testing, and analytical development meet stringent regulatory requirements. </span></p><p> </p><p><span style=\"color: black;\">Expanded Responsibilities:</span></p><ul style=\"list-style-type: disc; padding-left: 48px;\"><li><p><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Ensure all CMC activities comply with global regulatory standards including FDA, EMA, ICH, and other applicable authorities.</span></span></p></li><li><p><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Oversee:</span></span></p><ul style=\"list-style-type: circle; padding-left: 48px;\"><li><p><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Process development and scale-up activities</span></span></p></li><li><p><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Analytical method development, qualification, and validation</span></span></p></li><li><p><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Process validation and continued process verification</span></span></p></li><li><p><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Stability program design and monitoring</span></span></p></li></ul></li><li><p><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Review and approve key technical documentation including:</span></span></p><ul style=\"list-style-type: circle; padding-left: 48px;\"><li><p><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Batch records</span></span></p></li><li><p><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Validation protocols and reports</span></span></p></li><li><p><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Analytical methods and specifications</span></span></p></li><li><p><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Change controls and deviation investigations</span></span></p></li></ul></li><li><p><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Ensure manufacturing processes adhere to cGMP requirements and data integrity standards.</span></span></p></li></ul></td></tr><tr><td>25%</td><td>Yes</td><td><p>Initiates and designs the development and revision of operating procedures, policies,<span>Oversight of the CMO’s deliverables related to develop and submit CMC sections of regulatory dossiers to agencies like the FDA and EMA. </span></p><p> </p><p><span style=\"color: black;\">Expanded Responsibilities:</span></p><ul style=\"list-style-type: disc; padding-left: 48px;\"><li><p><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Lead the preparation, review, and finalization of CMC sections for regulatory submissions, such as INDs</span></span></p></li><li><p><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Coordinate compilation of manufacturing, analytical, validation, and stability data for submission.</span></span></p></li><li><p><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Ensure consistency between Quality Overall Summary (QOS) and detailed technical sections.</span></span></p></li><li><p><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Collaborate with Regulatory Affairs to address agency queries, deficiency letters, and information requests.</span></span></p></li><li><p><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Support preparation of responses to FDA/EMA questions within required timelines.</span></span></p></li><li><p><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Ensure lifecycle management updates (e.g., process changes, site changes, specification updates) are accurately reflected in post-approval submissions.</span></span></p></li><li><p><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Maintain regulatory intelligence awareness to anticipate evolving CMC requirements.</span></span></p></li></ul></td></tr><tr><td> </td><td> </td><td> </td></tr><tr><td> </td><td> </td><td> </td></tr><tr><td> </td><td> </td><td> </td></tr><tr><td> </td><td> </td><td> </td></tr><tr><td> </td><td> </td><td> </td></tr><tr><td> </td><td> </td><td> </td></tr></tbody></table></figure>",
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