Head of Regulatory CMC - Biologics & Advanced Therapy Medicinal Products (ATMP)

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

Benefits offered by this job

Medical, Dental, Vision, & Life ins.

Fitness reimbursement

Disability insurance

Paid vacation (15 days + year-end)+

Holidays + personal days

Sick time

Parental leave

401(k) with company match

Employee stock purchase plan

Tuition reimbursement

Employee Resource Groups

Job summary

Biogen in Cambridge, MA, is seeking a Head of Regulatory CMC for Biologics & ATMPs to lead a global regulatory strategy within the PO&T function. You will manage resources, set a vision, and ensure alignment between regulatory strategy, technical development, and manufacturing execution to drive timely approvals and lifecycle progression.

This hybrid role is based at Biogen's Headquarters in Cambridge, MA, and requires leading the CMC regulatory team with extensive experience in biologics/ATMPs

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

Biologics & ATMPs

Global submissions

Cross-functional collaboration

Regulatory policy knowledge

Industry associations

Negotiation with stakeholders

Team leadership

Education

PhD in Life Sciences

Regulatory affairs degree

Job description

About This Role

As the Head of Regulatory CMC - Biologics & Advanced Therapy Medicinal Products (ATMP), you will lead a dynamic team within the PO&T function, driving the regulatory strategy for biologics and ATMPs in Biogen's portfolio. Your role encompasses global, regional, and local accountability for all therapeutic areas relevant to these modalities. You will manage resources, set a vision, and ensure alignment between regulatory strategy, technical development, and manufacturing execution. By leading multiple projects in a fast-paced environment, you will play a crucial role in delivering on our product portfolio, providing strategic oversight to ensure timely approvals and lifecycle progression. Your leadership will be pivotal in fostering collaboration across the company, aligning regulatory strategies with manufacturing readiness and supply continuity.

This is a hybrid role to be based at our Headquarters in Cambridge, MA.

What You’ll Do

• 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.

Who You Are

You are a visionary leader with a deep understanding of regulatory sciences, skilled at navigating the complexities of biologics and ATMPs. Your strategic mindset and collaborative spirit enable you to forge strong partnerships across functions and drive innovative solutions. With your exceptional communication and problem-solving skills, you inspire confidence in stakeholders and lead your team to achieve ambitious goals. Your passion for regulatory excellence and dedication to advancing therapeutic solutions make you a vital asset to our organization.

Required Skills

• 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.

Job Level: Management

Additional Information

• The base compensation range for this role is: $241,000.00-$332,000.00
• 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 contrib