Associate Director, Regulatory CMC Small Molecule Lead
About The Position
As Associate Director, Regulatory CMC Small Molecule Lead, you will play a pivotal role in shaping and executing the global Regulatory Chemistry, Manufacturing and Controls (RegCMC) strategy for Biogen’s small molecule portfolio. You will be responsible for leading cross-functional regulatory CMC activities to ensure timely preparation and delivery of high-quality regulatory submissions that support product development, registration, and lifecycle management. This position requires a strategic thinker and strong communicator with deep regulatory CMC expertise who thrives in a global, matrixed environment. What You’ll Do The Associate Director, RegCMC Small Molecule Lead oversees the management and coordination of regulatory CMC activities across assigned projects and products.
Requirements
- Bachelor’s degree in Life Sciences, Engineering, Biotechnology, or a relevant Pharmaceutical Science; graduate degree preferred.
- Minimum 10+ years of relevant experience in the pharmaceutical industry or a regulatory authority CMC review capacity, including at least 7+ years in RegCMC.
- Proven success authoring and delivering CMC submissions for development and marketed products (chemical, biological, or oligonucleotide entities).
- Broad experience with registration procedures in ICH regions and direct communication with health authorities.
- In-depth knowledge of global regulations, ICH/GMP requirements, and CMC change management systems.
- Strong leadership and project management skills with ability to work cross-functionally and influence stakeholders.
- Demonstrated strategic thinking, problem-solving, and risk assessment abilities.
- Excellent written and verbal communication skills, including experience working across global time zones and cultures.
Responsibilities
- Lead cross-functional teams responsible for global RegCMC submissions (IND/IMPD/CTAs, NDAs/MAAs) and responses to Health Authority questions.
- Define and implement global RegCMC regulatory strategy to support development and commercial objectives.
- Communicate RegCMC strategies, risks, and plans effectively to leadership and project teams.
- Ensure regulatory strategies align with business goals and meet Health Authority requirements.
- Monitor and influence global RegCMC environment changes; contribute to internal process and policy improvements.
- Mentor and coach team members, supporting skill development within the RegCMC organization.
- Lead regulatory assessments, ensuring compliance with evolving global CMC regulations, and maintaining strong relationships with global health authorities.
Benefits
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
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What This Job Offers
Job Type
Full-time
Career Level
Director
