BiogenCambridge, Massachusetts, United States · Hybrid
$241k–$332k/yr
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 B…
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Cambridge, Massachusetts, United States · On-site
$37/hr–$82/hr
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Cambridge, Massachusetts, United States · On-site
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Cambridge, Massachusetts, United States · On-site
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Cambridge, Massachusetts, United States · On-site
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Posting Date 07/30/2026 1493 Cambridge St, Cambridge, Massachusetts, 02139-1047, United States of America $15K Bonus for New DaVita Teammates DaVita is seeking an RN to provide dialysis care in a hospital setting for pat…
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Biogen
Cambridge, Massachusetts, United States • Hybrid
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Lead the CMC regulatory team in developing and executing global regulatory strategies for biologics and ATMPs. Provide strategic oversight to ensure submission readiness, regulatory compliance, and alignment between manufacturing and technical development.
Requires an advanced degree or Ph.D. in Life Sciences or a related discipline. Candidates must have at least 15 years of experience in regulatory agencies or the pharmaceutical industry with a proven track record in global regulatory submissions.
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.
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.
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.
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.
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:
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 Biogen.
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.
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients’ lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities, to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth. With approximately 7,000 people worldwide, we are truly a global organization, headquartered in Cambridge, Massachusetts, which is also home to our research operations. Our international headquarters are based in Baar, Switzerland and we have world-class manufacturing facilities in North Carolina and Solothurn, Switzerland. We offer therapies globally through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries. For more information, please visit www.biogen.com. Community Guidelines: https://www.biogen.com/community-guidelines.html Follow us on social media – LinkedIn, Instagram, Facebook, X, and YouTube.
Offices: 225 Binney Street, Cambridge, MA 02142, US · Landis & Gyr-Strasse 3, Zug, CH 6300, CH · P.O. Box 14627, 5000 Davis Drive, Research Triangle Park, NC 27709, US
