Sr Manager, Global Regulatory Affairs, WCH
Biogen
Summary
The Sr. Manager, Global Regulatory Affairs (GRA) supports the regulatory strategy and execution for assigned programs, working closely with the Global Regulatory Lead (GRL) and cross-functional teams. This role contributes to the development and implementation of regulatory submissions across multiple regions, ensuring alignment with global regulatory requirements and timelines. The Manager also serves as a key point of contact for regulatory operations and external partners (e.g., CROs), and provides backup support for regulatory activities within the team.
Job description
About This Role
The Sr. Manager, Global Regulatory Affairs (GRA) supports the regulatory strategy and execution for assigned programs, working closely with the Global Regulatory Lead (GRL) and cross-functional teams. This role contributes to the development and implementation of regulatory submissions across multiple regions, ensuring alignment with global regulatory requirements and timelines. The Manager also serves as a key point of contact for regulatory operations and external partners (e.g., CROs), and provides backup support for regulatory activities within the team.
What You'll Do
- Collaborate with the Global Regulatory Lead to support regulatory strategy and execution for assigned programs.
- Participate in cross-functional project teams to provide regulatory input and ensure alignment on submission planning and labeling strategy.
- Lead or support the review of regulatory submission packages, including INDs, CTAs, NDAs/BLAs, and supplemental submissions.
- Manage health authority query responses, ensuring timely and accurate communication and resolution.
- Coordinate with Regulatory Operations and CROs to facilitate submission logistics and document delivery.
- Provide guidance on US labeling precedence and support implementation of US labeling across functions.
- Maintain and update regulatory systems (e.g., GRIT) to reflect submission approvals related to supply release.
- Serve as a backup for other regulatory team members during absences, ensuring continuity of regulatory support.
Who You Are
You are a hands-on Global Regulatory Affairs professional with experience managing and supporting IND, CTA, NDA, and BLA submissions across multiple regions and working directly with health authorities and cross-functional development teams. You thrive in a fast-paced biotech environment, bringing strong regulatory execution, project management, and submission expertise to drive programs forward while ensuring global regulatory compliance.
Required Skills
- Bachelor's degree with 5+ years of experience in regulatory affairs within the pharmaceutical or biotechnology industry.
- Strong knowledge and understanding of global regulatory requirements, including interpretation of regulations, guidelines, and policy statements
- Demonstrated ability to manage regulatory submissions across multiple regions and submission types (IND, CTA, NDA/BLA).
- Excellent operational competencies, including planning, organization, and project management skills.
- Strong oral and written communication skills, with the ability to clearly convey regulatory concepts and updates to cross-functional teams.
- Proven ability to build collaborative relationships across functions and contribute to innovative problem-solving.
- Experience with regulatory systems and tools such as Veeva Vault, Docubridge, and CTIS.
- Ability to work independently and serve as a reliable team member in a fast-paced, matrixed environment
Preferred Skills
- Management of CTA
- Supporting BLA
Requirements
- Bachelor's degree with 5+ years of experience in regulatory affairs within the pharmaceutical or biotechnology industry
- Strong knowledge and understanding of global regulatory requirements, including interpretation of regulations, guidelines, and policy statements
- Demonstrated ability to manage regulatory submissions across multiple regions and submission types (IND, CTA, NDA/BLA)
- Excellent operational competencies, including planning, organization, and project management skills
- Strong oral and written communication skills, with the ability to clearly convey regulatory concepts and updates to cross-functional teams
- Proven ability to build collaborative relationships across functions and contribute to innovative problem-solving
- Experience with regulatory systems and tools such as Veeva Vault, Docubridge, and CTIS
- Ability to work independently and serve as a reliable team member in a fast-paced, matrixed environment
- Preferred: Management of CTA
- Preferred: Supporting BLA
Benefits
- Medical, Dental, Vision & Life Insurance
- Fitness & Wellness Programs
- Short- & Long-Term Disability
- 15 Days Paid Vacation
- End-of-Year Shutdown
- 12 Paid Holidays
- 3 Personal Significance Days
- 80 Hours Sick Time
- Paid Maternity & Parental Leave
- 401(k) Matching
- Employee Stock Purchase Plan
- Tuition Reimbursement
- Employee Resource Groups
Company overview
Founded in 1978, Biogen is a leading global biotechnology company headquartered in Cambridge, Massachusetts, specializing in the development and commercialization of innovative therapies for serious neurological and neurodegenerative diseases. As one of the oldest independent biotechnology companies in the United States, Biogen has established itself as a pioneer in neuroscience, focusing on difficult-to-treat conditions where few or no treatment options exist. The company's portfolio includes groundbreaking treatments for multiple sclerosis, spinal muscular atrophy, Alzheimer's disease, ALS, and Friedreich's ataxia. With approximately 7,000 employees worldwide, Biogen operates through a global network that includes research and development hubs in Cambridge, Research Triangle Park in North Carolina, and South San Francisco, along with world-class manufacturing facilities in the United States and Switzerland. The company's commitment to scientific innovation is demonstrated by its Nobel Prize-winning founders and its receipt of the U.S. National Medal of Technology and Innovation. Biogen's patient-centric approach drives its mission to deliver transformative medicines that improve lives while creating sustainable value for shareholders and communities.