Biogen · 1 day ago
Sr. Manager, Global Regulatory Affairs
San Francisco, CA
Full-time
Hybrid
Senior Level
$140K/yr - $187K/yr
5+ years expBiogen is a mid-sized biotechnology company committed to excellence and innovation. The Sr. Manager, Global Regulatory Affairs supports regulatory strategy and execution for assigned programs, collaborating with cross-functional teams to ensure alignment with global regulatory requirements and timelines.
BiotechnologyHealth CareNeuroscienceTherapeutics
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
Qualification
Required
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
Preferred
Management of CTA
Supporting BLA
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
Company
Biogen
Biogen is an American biotechnology company that provides therapeutics for neurological, autoimmune, and rare diseases.
Founded in 1978Cambridge, Massachusetts, USA
5001-10000 employees
H1B Sponsorship
Biogen has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (100)
2024 (93)
2023 (101)
2022 (134)
2021 (104)
2020 (114)
Funding
Current Stage
Public CompanyTotal Funding
$1.5BKey Investors
JP Morgan
2023-08-28Post Ipo Debt· $1.5B
1991-09-27IPO
Leadership Team
Robin C. Kramer
Executive Vice President, Chief Financial Officer
Priya Singhal
Executive Vice President, Head of Development
Recent News
Pharmaceutical Technology
2026-01-05
Company data provided by crunchbase