Biogen · 1 day ago
Sr. Manager, Global Regulatory Affairs
Cambridge, MA
Full-time
Hybrid
Senior Level
$140K/yr - $187K/yr
5+ years expBiogen is a mid-sized biotechnology company committed to excellence and innovation in delivering life-changing medicines. The Sr. Manager, Global Regulatory Affairs will lead US regulatory strategies, oversee regulatory filings with the FDA, and ensure compliance with regulatory requirements while fostering collaboration across teams.
BiotechnologyHealth CareNeuroscienceTherapeutics
Responsibilities
Direct US regulatory strategies for assigned projects, supporting the global clinical development and lifecycle
Identify and assess regulatory risks associated with product development and define strategies to mitigate these risks
Set strategic direction and lead the US regulatory submission process, including INDs, NDAs, sNDAs and briefing packages
Support the development of the US label and represent US regulatory strategy at global labeling team meetings
Monitor and analyze FDA activities and assess their specific impact on your projects
Foster positive interactions with the FDA
Represent the department in US project teams, committees, and external meetings
Qualification
Required
Bachelor's Degree in Life Science or related discipline with 7 years experience, Masters degree with 5 years experience
Strong and proven experience within the pharmaceutical/biotechnology industry, including significant experience in Regulatory Affairs Strategy
Hands-on experience in preparing major regulatory filings with the FDA and supportive amendments or supplements
Strong leadership and communication skills, with the ability to guide and collaborate effectively across functions and levels of the organization
Energetic, creative, analytical problem solver who acts independently yet communicates broadly
Strategic thinker with the ability to anticipate and mitigate regulatory risks
Expertise in the current regulatory landscape and evolving guidance
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
thecanadianpressnews.ca
2025-12-24
Company data provided by crunchbase