Associate Director, CMC Regulatory Affairs

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    "ExternalDescriptionStr": "<p style=\"line-height:normal;\"><span style=\"color:#333333;\"><span style=\"font-size:10.0pt;\">Regulatory Affairs Chemistry, Manufacturing, and Controls (CMC), plays a critical role in supporting a diverse portfolio of small molecule development programs and marketed products across multiple sites. Our team is driven by strategic excellence, collaborative spirit, and a commitment to delivering high-quality regulatory outcomes.</span></span></p><p style=\"line-height:normal;\"><span style=\"color:#333333;\"><span style=\"font-size:10.0pt;\">We are seeking an experienced <strong>Associate Director, Regulatory Affairs CMC</strong> to serve as the&nbsp;</span></span><span style=\"font-size:10.0pt;\">Regulatory CMC Lead</span><span style=\"color:#333333;\"><span style=\"font-size:10.0pt;\"> for a late-stage small molecule development program. This individual will be responsible for providing strategic regulatory direction and managing CMC related activities in close partnership with cross-functional development teams, ensuring compliance with global regulatory standards and alignment with internal program goals.</span></span></p><p style=\"line-height:normal;\"><span style=\"color:#333333;\"><span style=\"font-size:10.0pt;\">This position is eligible for a hybrid workplace model, requiring work to be completed onsite at our Waltham, MA office. This role is not eligible for fully remote work.</span></span></p><p style=\"line-height:normal;\"><span style=\"color:#333333;\"><span style=\"font-size:10.0pt;\"><strong>Key Responsibilities:</strong></span></span></p><ul style=\"list-style-type:disc;\"><li style=\"color:#333333;line-height:normal;tab-stops:list .5in;\"><span style=\"font-size:10.0pt;\">Lead regulatory CMC strategy and execution for assigned development programs.</span></li><li style=\"color:#333333;line-height:normal;tab-stops:list .5in;\"><span style=\"font-size:10.0pt;\">Provide regulatory and scientific expertise to shape CMC strategies for development programs.</span></li><li style=\"color:#333333;line-height:normal;tab-stops:list .5in;\"><span style=\"font-size:10.0pt;\">Collaborate cross-functionally with technical and regulatory teams to support product development and lifecycle management.</span></li><li style=\"color:#333333;line-height:normal;tab-stops:list .5in;\"><span style=\"font-size:10.0pt;\">Oversee preparation, review and submission of high-quality CMC sections for investigational and registration submission (INDs, IMPDs, NDAs, MAAs and amendments) in alignment with Health Authority requirements.</span></li><li style=\"color:#333333;line-height:normal;tab-stops:list .5in;\"><span style=\"font-size:10.0pt;\">Work within the department and cross-functionally to establish regulatory CMC strategies for product development and commercialization.</span></li><li><p style=\"line-height:normal;tab-stops:list .5in;\"><span style=\"color:#333333;\"><span style=\"font-size:10.0pt;\">Prepare and communicate CMC Risk Management Assessments, contingency plans, and lessons learned on major submissions and escalate with management as appropriate.</span></span></p></li><li><p style=\"line-height:normal;tab-stops:list .5in;\"><span style=\"color:#333333;\"><span style=\"font-size:10.0pt;\">Lead teams in preparation of responses to Health authority related queries through cross functional collaboration.</span></span></p></li><li><p style=\"line-height:normal;tab-stops:list .5in;\"><span style=\"color:#333333;\"><span style=\"font-size:10.0pt;\">Develop strategies and lead teams in the preparation of key CMC related Health Authority meetings, including development of meeting information packages.</span></span></p></li><li style=\"color:#333333;line-height:normal;tab-stops:list .5in;\"><span style=\"font-size:10.0pt;\">Foster relationships and proactively communicating with key stakeholders.</span></li><li style=\"color:#333333;line-height:normal;tab-stops:list .5in;\"><span style=\"font-size:10.0pt;\">Develop and implement best practices based on current/emerging industry trends and relevant Health Authority guidance and regulations.</span></li></ul><p style=\"line-height:normal;\"><span style=\"color:#333333;\"><span style=\"font-size:10.0pt;\"><strong>Skills and Abilities:</strong></span></span></p><ul style=\"list-style-type:disc;\"><li style=\"color:#333333;line-height:normal;tab-stops:list .5in;\"><span style=\"font-size:10.0pt;\">In-depth understanding of relevant Health Authority regulations, guidelines and regulatory trends (FDA, EMA, TGA, Health Canada, ICH, WHO).</span></li><li style=\"color:#333333;line-height:normal;tab-stops:list .5in;\"><span style=\"font-size:10.0pt;\">In-depth knowledge of drug development process within pharmaceutical and/or biopharmaceutical industries.</span></li><li><p style=\"tab-stops:list .5in;\"><span style=\"color:#333333;\"><span style=\"font-size:10.0pt;line-height:115%;\">Monitor global developments in CMC regulations, guidelines, and industry trends, to evaluate their potential impact on Alkermes’ products.</span></span></p></li><li><p style=\"tab-stops:list .5in;\"><span style=\"color:#333333;\"><span style=\"font-size:10.0pt;line-height:115%;\">Good judgement in identifying risks and elevating issues to Regulatory Management.</span></span></p></li><li><p style=\"tab-stops:list .5in;\"><span style=\"color:#333333;\"><span style=\"font-size:10.0pt;line-height:115%;\">Advanced writing skills with ability to deliver high quality regulatory documents.</span></span></p></li><li><p style=\"tab-stops:list .5in;\"><span style=\"color:#333333;\"><span style=\"font-size:10.0pt;line-height:115%;\">Ability to influence decisions and help develop solutions.&nbsp;</span></span></p></li><li><p style=\"tab-stops:list .5in;\"><span style=\"color:#333333;\"><span style=\"font-size:10.0pt;line-height:115%;\">Excellent oral communication skills.</span></span></p></li><li><p style=\"tab-stops:list .5in;\"><span style=\"color:#333333;\"><span style=\"font-size:10.0pt;line-height:115%;\">Commitment to continuous improvement and best practices.</span></span></p></li><li><p style=\"tab-stops:list .5in;\"><span style=\"color:#333333;\"><span style=\"font-size:10.0pt;line-height:115%;\">Ability to manage multiple priorities in a fast-paced environment.</span></span></p></li></ul><p style=\"line-height:normal;\"><span style=\"color:#333333;\"><span style=\"font-size:10.0pt;\"><strong>Basic Qualifications:</strong></span></span></p><ul style=\"list-style-type:disc;\"><li style=\"color:#333333;line-height:normal;tab-stops:list .5in;\"><span style=\"font-size:10.0pt;\">Bachelor of Science in a scientific discipline; post graduate degree preferred&nbsp;</span></li><li><p style=\"line-height:normal;tab-stops:list .5in;\"><span style=\"color:#333333;\"><span style=\"font-size:10.0pt;\">7+ years of experience in the pharmaceutical/biopharmaceutical industry, including direct experience in drug development.</span></span></p></li><li><p style=\"line-height:normal;tab-stops:list .5in;\"><span style=\"color:#333333;\"><span style=\"font-size:10.0pt;\">3+ years of direct experience in Regulatory Affairs CMC, including Regulatory CMC lead experience required.</span></span></p></li></ul><p style=\"line-height:normal;tab-stops:list .5in;\"><span style=\"color:#333333;\"><span style=\"font-size:10.0pt;\"><strong>Preferred Qualifications:</strong></span></span></p><ul style=\"list-style-type:disc;\"><li><p style=\"tab-stops:list .5in;\"><span style=\"color:#333333;\"><span style=\"font-size:10.0pt;line-height:115%;\">Proven track record leading global regulatory CMC strategies across different stages of product development.</span></span></p></li><li><p style=\"tab-stops:list .5in;\"><span style=\"color:#333333;\"><span style=\"font-size:10.0pt;line-height:115%;\">Proven ability to lead and manage junior Regulatory CMC team members is a plus.</span></span></p></li></ul><p style=\"tab-stops:list .5in;\"><span style=\"color:#333333;\"><span style=\"font-size:10.0pt;line-height:115%;\">#LI-HB1</span></span></p><p style=\"tab-stops:list .5in;\">&nbsp;</p>",
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    "CorporateDescriptionStr": "<div>\n <div>\n  <p><b>Why join Team Alkermes?</b></p>\n  <p>Alkermes applies its decades of deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we seek to make a meaningful difference in the way people manage their diseases. We have a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia, bipolar I disorder and narcolepsy, and a pipeline of clinical and preclinical candidates in development for various psychiatric and neurological disorders.</p>\n  <p></p>\n  <p>We are proud to have been recognized as an employer of choice by many national organizations. In 2024 and 2025, we were certified as a Great Place to Work in the U.S. and named one of Massachusetts’ Top Places to Work by the Boston Globe, a Best Place to Work in Greater Cincinnati by the Cincinnati Business Courier and recognized as a Best Place to Work in BioPharma by Fortune Magazine.&nbsp;</p>\n </div>\n <div>\n  <p>Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other characteristic protected by local, state or federal law.&nbsp; Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. &nbsp;Alkermes is an E-Verify employer.</p>\n </div>\n</div>",
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