Sr. Manager, Global Regulatory Affairs

Biogen•San Francisco, CA

2d•$140,000 - $187,000•Hybrid

About The Position

This position will be hybrid to our San Francisco, CA site 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.

Requirements

Bachelor’s degree with minimum of 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

Nice To Haves

Management of CTA
Supporting BLA

Responsibilities

Collaborate with the GRL 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.

Benefits

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