Regulatory CMC Leader - Biologics & ATMP (Hybrid)

Regulatory Jobs; Cambridge (MA); Hybrid; USD 241,000 - 332,000; Full time

Benefits offered by this job

Healthcare benefits

Stock plan

Tuition reimbursement

Paid time off

Job summary

Biogen seeks Head of Regulatory CMC for Biologics & ATMPs to lead a global regulatory strategy, align with development and manufacturing, and drive lifecycle progression across therapeutic modalities.

You will manage resources, partner with cross-functional teams, and engage Health Authorities to enable timely approvals. This role is hybrid based at Biogen's Cambridge, MA headquarters.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Regulatory leadership

Global submissions

Biologics & ATMPs

Regulatory strategy

Cross-functional collaboration

Regulatory agencies knowledge

Industry associations

Global development experience

Education

PhD/advanced degree in life sciences

Job description

Biogen seeks Head of Regulatory CMC for Biologics & ATMPs to lead a global regulatory strategy, align with development and manufacturing, and drive lifecycle progression across therapeutic modalities.

You will manage resources, partner with cross-functional teams, and engage Health Authorities to enable timely approvals. This role is hybrid based at Biogen's Cambridge, MA headquarters.