About This Role
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. Primary duties include:
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.
This position is also responsible for leading regulatory assessments, ensuring compliance with evolving global CMC regulations, and maintaining strong relationships with global health authorities.
Who You Are
You are an experienced regulatory professional with deep technical understanding of CMC development for small molecule products. You bring a strategic mindset, a collaborative spirit, and the ability to lead global cross-functional teams to achieve regulatory success.
Required Skills
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.
Additional Information
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to:
- 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
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
Top Skills
Biogen Cambridge, Massachusetts, USA Office
225 Binney Street, Cambridge, MA, United States, 02142
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