Associate Director, Regulatory Affairs, CMC

Position Summary

AD, Regulatory Affairs CMC is responsible for developing and implementing global regulatory CMC strategies to secure and maintain market access for assigned product(s). The role manages CMC aspects of compounds (large molecules) through all phases of development, post‑approval, and life cycle, coordinating with key internal stakeholders.

• Serve as the regulatory CMC representative on project teams.
• Provide CMC regulatory support and guidance for assigned projects and interface with R&D, Project Management, Manufacturing, Quality, Supply Chain, Regulatory colleagues, third‑party laboratories, global collaboration partners, and contract manufacturers.
• Manage interactions with FDA and other global regulatory authorities to ensure acceptance, rapid review and approval of marketing applications, supplements/variations, clinical trial applications, and other CMC submissions.
• Author and lead CMC content for Health Authority meeting briefing packages, including development of CMC strategy, preparation of CMC‑related questions, supporting data summaries, and responses to Health Authority feedback in collaboration with global regulatory and cross‑functional teams.
• Develop and implement effective regulatory CMC strategies for global submissions, interpreting and applying local regulations and guidance throughout the product life cycle.
• Manage, prepare, and/or author CMC document packages for global regulatory submissions, including primary authorship and/or leadership of Module3 (Quality) sections for INDs, CTAs, IMPDs, BLAs, MAAs, supplements, and variations.
• Prepare high‑quality responses to Health Authority questions, balancing regulatory requirements with corporate objectives.
• Manage timelines in cooperation with Project Management on assigned projects.
• Review technical reports and CMC sections of IND, CTA, BLA, MAA, and other global submissions to support clinical trials and marketing applications and their amendments in accordance with regulatory requirements, strategies, and commitments.
• Work with regulatory CROs to identify regional/country‑specific CMC requirements to support global applications.
• Evaluate proposed manufacturing changes for global impact to ongoing and existing filings and provide strategic regulatory guidance for optimal implementation.
• Actively participate as a member of global regulatory teams and CMC subteams.
• Support and manage regulatory aspects of CMC Operations, including authoring, reviewing, and/or approving SOPs, CAPAs, etc.
• Maintain knowledge of the global competitive landscape, regulatory environment, regulations, and CMC guidance, providing interpretation to internal stakeholders and initiating process improvements as appropriate.
• Other duties as assigned.

• Minimum 8+ years of experience in a global CMC regulatory affairs position with expertise in biologics and deep experience in development products and commercial product lifecycle, including Phase1‑3 and marketed products.
• Prior success in filing marketing applications, supplements, and variations for biologic products within timelines; global submission experience desired.
• Strong knowledge of U.S. and international GMP quality regulations, current industry practices, and experience with interpretation and application to development projects and marketed product regulatory issues.
• Demonstrated experience in effective collaboration with multiple stakeholders both internally and externally, including FDA and other Health Authorities.
• Proficient in coaching, training, and mentoring teams.
• Strong negotiating skills and ability to think creatively and develop creative solutions.
• Ability to prioritize and handle multiple projects simultaneously.
• Excellent interpersonal, oral, and written communication skills and strong organizational skills with demonstrated ability to manage and adhere to timelines.
• Proven ability to build trust and respect within the organization.

• BS/BA in Biochemistry, Biology, or Pharmaceutical Science; advanced degree preferred.

• Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint) and Veeva Data Management…