Manager, Regulatory Affairs

About This Role

As Manager, Regulatory Affairs, you will lead regional Regulatory Affairs (RA) activities for biosimilars beyond centralized authorizations, coordinating with Affiliate RA to identify and fulfill national regulatory requirements to support successful product launches. You will oversee product updates across multiple countries and manage key national regulatory process steps, including risk minimization measures (RMMs). This role requires strong cross-functional collaboration, building and maintaining multiple interfaces with internal stakeholders, vendors, Affiliate RA, and medical teams to ensure timely and compliant execution.

What You'll Do

• Lead the development and execution of Biogen's regulatory strategies for assigned projects and products.
• Serve as Biogen's regulatory representative with strategic partner(s), ensuring alignment on regulatory strategy.
• Identify and assess regulatory risks associated with product development, with guidance from senior team members.
• Coordinate the preparation of regulatory documents and submission dossiers in close collaboration with Affiliate RA.
• Manage the development and maintenance of additional risk minimization measures (aRMMs), support labeling activities, and provide CMC regulatory support as needed.
• Oversee regulatory review of promotional materials, sales training content, and external communications, partnering closely with Affiliate RA.
• Track, report, and drive progress of registration and lifecycle activities to support timely approvals, implementation, and launches.
• Provide regulatory input and support across cross-functional project teams to enable successful project delivery.
• Manage day-to-day activities of regulatory vendors and ensure high-quality, timely outputs.
• Build strong relationships with affiliate and distributor teams to support biosimilar regulatory execution.
• Maintain effective collaboration with internal and external stakeholders, including vendors, corporate partners, and regulatory authorities when needed.
• Stay current on regional legislation and ensure compliance with Biogen policies, quality standards, and business requirements.
• Provide training, guidance, and ongoing support to RA colleagues.

• Bachelor's degree in pharmacy, chemistry, biology, pharmacology or related life sciences subject.
• A minimum of 3 years' experience in pharmaceutical/biotechnology industry or in scientific research preferred with at least 1 year experience in Regulatory Affairs.
• Experience and knowledge in the preparation of regulatory submissions and supportive amendments or supplements.
• Ability to work independently with minimal direction and within project teams.
• Demonstrate good communication skills and solid organizational skills, including the ability to prioritize workload.
• Good interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff.
• Effective cross-cultural awareness and capabilities.
• Some experience in interfacing with relevant regulatory authorities.
• Knowledge and understanding of applicable regulations and regulatory pathways.
• Some experience in interpretation of regulations, guidelines, policy statements, etc.
• Sensitivity for a multicultural/multinational environment.
• Detail oriented with effective written and oral communication skills.
• Good verbal and written English skills.