We are seeking an experienced and strategic Senior Director, Regulatory Affairs – CMC to lead global CMC regulatory strategy across a diverse portfolio of small molecule and biologic development programs from early clinical development through commercialization.
This role is a key leadership position within the Regulatory organization and will serve as the global CMC regulatory lead for assigned programs. The successful candidate will partner cross-functionally with CMC Technical Operations, Quality, Clinical, and Commercial teams to ensure regulatory strategies are aligned with development and lifecycle objectives.
This is a hybrid role based in Boston, requiring on-site presence three days per week.
Regulatory Strategy & Execution
- Develop and lead global CMC regulatory strategies for small molecule and biologic programs (IND/CTA through NDA/BLA/MAA and post-approval lifecycle management).
- Serve as the Global Regulatory CMC Lead on cross-functional program teams.
- Author, review, and approve CMC sections (Modules 2 and 3) of regulatory submissions.
- Oversee preparation and submission of INDs, CTAs, NDAs, BLAs, MAAs, amendments, supplements, annual reports, and variations.
- Lead regulatory impact assessments for manufacturing changes, comparability strategies, and change controls.
Health Authority Engagement
- Lead preparation for and participate in Health Authority meetings (FDA, EMA, and other global agencies).
- Develop briefing materials and responses to regulatory queries.
- Serve as the primary CMC regulatory interface with global regulatory agencies.
Lifecycle & Compliance
- Provide strategic oversight for post-approval lifecycle management activities.
- Ensure regulatory compliance for commercial products through effective change management.
- Monitor evolving regulatory guidance (FDA, EMA, ICH) and proactively assess impact on development programs.
Leadership & Collaboration
- Provide mentorship and technical guidance to regulatory team members.
- Partner with Technical Operations, Analytical Development, Manufacturing, Quality, and Supply Chain to align regulatory strategies with operational execution.
- Support due diligence activities for potential business development opportunities.
- Contribute to regulatory planning, budgeting, and resource forecasting.
Education
- Master’s degree or higher (MS, PhD, PharmD) in a scientific discipline required.
- Advanced scientific training strongly preferred.
Experience
- Minimum 15+ years of pharmaceutical or biotechnology industry experience.
- Minimum 8–10 years of direct Regulatory Affairs CMC experience.
- Demonstrated experience supporting both small molecule and biologic programs.
- Proven track record of leading successful IND, NDA, BLA, and/or MAA submissions.
- Experience with commercial product lifecycle management and post-approval changes.
- Prior experience leading Health Authority interactions and regulatory negotiations.
- Experience in a fast-paced biotech environment preferred.
Knowledge & Skills
- Strong working knowledge of FDA, EMA, ICH, and global CMC regulatory requirements.
- Deep understanding of drug development processes from early phase through commercialization.
- Ability to assess regulatory risk and develop mitigation strategies.
- Excellent written and verbal communication skills.
- Strong leadership presence with ability to influence cross-functional teams.
- Demonstrated ability to manage multiple programs and shifting priorities.
What We Offer
- Competitive compensation and equity participation
- Comprehensive benefits package
- Collaborative and science-driven culture
- Opportunity to contribute to innovative therapies with meaningful patient impact