Head of Regulatory CMC, Biologics & Advanced Therapy Medicinal Products

Biogen

Head of Regulatory CMC overseeing global biologics and ATMP regulatory strategies at Biogen. Leading a team to ensure compliance and timely approvals in a dynamic environment.

Posted 7/31/2026full-timeCambridge • Massachusetts • 🇺🇸 United StatesLead💰 $241,000 - $332,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in leading CMC regulatory strategies for biologics and ATMPs, ensuring compliance and submission readiness while effectively collaborating with cross-functional teams and regulatory agencies.

Highest-signal resume keywords

Advanced Degree In Life Sciences15 Years Of Regulatory ExperienceLeadership In Regulatory SciencesGlobal Regulatory Submissions For BiologicsUnderstanding Of International Regulations

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

CMC Regulatory Strategy DevelopmentRegulatory Risk AssessmentRegulatory ComplianceRegulatory Submission ReviewPost-Approval Lifecycle Oversight

Soft Skills

Collaboration SkillsNegotiation Skills

Industry Keywords

BiologicsATMPsHealth AuthoritiesPharmaceutical IndustryIndustry Associations

About the role

Key responsibilities & impact

Lead the CMC regulatory team in the development and execution of global CMC regulatory strategies for biologics and ATMPs.
Assess regulatory risks and develop mitigation approaches to support timely product approvals.
Ensure submission readiness and regulatory compliance across all phases of development and commercialization.
Guide global interactions with Health Authorities for CMC topics, preparing briefing materials and responses to agency questions.
Provide oversight for post-approval lifecycle activities, evaluating manufacturing and analytical changes for regulatory submissions.
Represent the regulatory function in evaluating new product opportunities, coordinating with Technical Operations, Quality, and Supply Chain.
Participate in external industry meetings and forums, organizing discussions and delivering presentations.
Offer recommendations and risk assessments to influence decision-making in governance forums.
Review and approve regulatory submissions ensuring alignment with global requirements and business timelines.

Requirements

What you’ll need

Advanced Degree or Ph.D. in Life Sciences, Pharmacy, Medicines, or related discipline
Minimum of 15 years of experience within regulatory agencies or the Pharmaceutical Industry
Significant leadership experience in Regulatory Sciences
Proven track record of successful global regulatory submissions and approvals for biologics and/or ATMPs
Significant understanding of international regulations and policy-setting processes of major regulatory agencies
Active engagement in major industry associations, conferences and forums
Strong collaboration and negotiation skills with cross-functional teams
Experience working across global development and manufacturing networks, including external partners

Benefits

Comp & perks

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