Associate Director, Regulatory Affairs

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    "description": "<h2>Overview</h2>\n<p><strong><u>Who We Are:</u></strong></p>\n<p> </p>\n<p>At Dendreon, we’re transforming the battle against cancer with personalized immunotherapy. Our flagship product, <strong>PROVENGE® (sipuleucel-T)</strong>, was the first FDA-approved immunotherapy for metastatic castrate-resistant prostate cancer, utilizing a patient’s own immune cells to fight the disease.</p>\n<p> </p>\n<p>If you’re driven by the opportunity to make a meaningful impact on cancer patients' lives, we invite you to join our team. With Immunotherapy Manufacturing Facilities in Seal Beach, CA, and Union City, GA, a strong Research & Development group in Seattle, WA, and a highly skilled Commercial team across the nation, Dendreon is at the forefront of cancer treatment innovation.</p>\n<p> </p>\n<p><strong><u>Core Values:</u></strong></p>\n<p> </p>\n<ul>\n <li><strong>Put Patients First: </strong>Every day is an opportunity to improve the lives of those living with cancer.</li>\n <li><strong>Act with Integrity: </strong>We commit to transparency, honesty, and always doing what’s right.</li>\n <li><strong>Build Trust: </strong>Trust is earned through candid, open communication and a collaborative approach.</li>\n <li><strong>Raise the Bar: </strong>We embrace continuous improvement and innovation, always striving to elevate our people.</li>\n <li><strong>Drive Results: </strong>We are accountable to each other and deliver success together.</li>\n</ul>\n<p><strong><u>Job Summary: </u></strong><u> </u></p>\n<p>The Associate Director of Regulatory Affairs develops and executes global regulatory strategies to support product development, lifecycle management, and commercialization objectives. Provides both strategic planning and tactical execution of product development, regulatory submission/approval and post-approval activities for advanced therapy.</p>\n<p> </p>\n<p><strong>NOTE: This role requires on-site presence at our Seal Beach, CA location minimum 4 days per week.</strong></p>\n<h2>Responsibilities</h2>\n<ul>\n <li>Oversees regulatory compliance activities and ensures organizational adherence to applicable FDA, international, and regional regulatory requirements.</li>\n <li>Partners with Quality, Manufacturing, Clinical, Commercial, and Technical Operations teams to assess regulatory changes and implement appropriate operational, product, and procedural modifications.</li>\n <li>Develops processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored.</li>\n <li>Establishes and maintains processes to ensure regulatory licenses, registrations, certifications, filings, and regulatory commitments are appropriately tracked, maintained, and renewed.</li>\n <li>Accountable for the quality, completeness, and timely submission of regulatory applications and health authority responses.</li>\n <li>Directly manages Regulatory Affairs personnel and may oversee consultants, contractors, and external regulatory partners.</li>\n <li>Develops, implements, and maintains regulatory policies, procedures, and compliance monitoring processes to support regulatory adherence and operational excellence.</li>\n <li>Anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements.</li>\n <li>Provides regulatory leadership in the investigation, assessment, and resolution of regulatory compliance issues, deviations, and corrective actions.</li>\n <li>Develops materials for and leads key interactions with regulatory authorities. </li>\n <li>Maintains awareness and assesses the impact of additions/changes to regulations and guidelines and evaluates relevance to company and product interests.</li>\n <li>Provides leadership, coaching, performance management, and professional development for Regulatory Affairs personnel.</li>\n <li>Oversees recruitment, onboarding, and development of Regulatory Affairs team members.</li>\n <li>Provides strategic regulatory leadership throughout the product lifecycle, from early development through commercialization and post-marketing activities.</li>\n <li>Serves as Regulatory Affairs representative on Promotional Review Committees and reviews promotional materials for regulatory compliance.</li>\n <li>Supports regulatory inspection readiness activities and responses to regulatory observations and inquiries.</li>\n <li>Leads preparation for and participation in FDA, EMA, NMPA, and other health authority meetings, including strategy development and briefing document preparation.</li>\n <li>Leads multidisciplinary teams in the authoring of regulatory submissions such as CMC submissions, protocols, CSRs, Annual Reports to INDs /BLAs, etc.  A hands-on approach is vital.</li>\n <li>Responsibilities include providing guidance, regulatory expertise, and advice to senior management and other company personnel to achieve goals for regulatory timelines, strategy, CMC, nonclinical and clinical testing.</li>\n <li>Provides oversight to post-marketing activities for commercial product including biological product deviation reporting, assessment of manufacturing changes, labeling, advertising and promotional materials, etc.</li>\n <li>Plans, manages, and executes regulatory activities, including submission and maintenance of US and international regulatory filings.</li>\n <li>Leads global regulatory or technical initiatives or acts as a Regulatory expert in cross-functional initiatives.</li>\n <li>Contributes to the development, management, and oversight of departmental budgets and resource planning activities.</li>\n</ul>\n<h2>Qualifications</h2>\n<ul>\n <li>BS required; MS, PharmD, PhD, or other advanced scientific degree preferred.</li>\n <li>10+ years of progressive Regulatory Affairs experience within the biotechnology, pharmaceutical, or life sciences industry, including experience leading complex regulatory submissions and cross-functional initiatives.</li>\n <li>5+ years of progressive leadership experience with demonstrated success influencing cross-functional teams and driving regulatory outcomes.</li>\n <li>Pre- and Post-approval experience with advanced cellular therapy products is highly desired.</li>\n <li>Prior drug development experience.</li>\n <li>Experience with health authorities in China is desirable. </li>\n <li>Demonstrated leadership, collaboration, negotiation, and influencing skills with a proven ability to solve complex regulatory challenges.</li>\n <li>In-depth knowledge of FDA, cGMP and ICH regulatory requirements.</li>\n <li>The ability to travel domestically and internationally as needed.</li>\n</ul>\n<p><strong><u>Working Conditions and Physical Requirements:</u></strong></p>\n<ul>\n <li>Dendron Pharmaceuticals LLC is a EEO/AA employer M/F/D/V.</li>\n <li>Dendreon operates in a fast-paced, patient-centric, and competitive environment.</li>\n <li>Team cohesiveness, direct and specific communication, and independent problem-solving are essential to succeed in this position.</li>\n <li>Some travel required.</li>\n <li>While performing the duties of this job, the employee is regularly required to sit, stand, walk, and use hands to operate a computer keyboard, mouse, and mobile phone.</li>\n</ul>",
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