Biogen · 10 hours ago
Senior Manager, Regulatory CMC Lead
San Francisco, CA
Full-time
Hybrid
Senior Level
$138K/yr - $185K/yr
7+ years expBiogen is a mid-sized biotechnology company committed to excellence and innovation. They are seeking a Senior Manager, Regulatory CMC Lead to provide regulatory CMC expertise, support projects, and lead regulatory submissions while collaborating with key stakeholders. This role is crucial for ensuring compliance and facilitating project advancement within the regulatory framework.
BiotechnologyHealth CareNeuroscienceTherapeutics
Responsibilities
Provide regional strategic and operational regulatory CMC expertise and support in cross-functional teams
Prepare and deliver CMC regulatory operational plans and submissions in assigned regions and support the preparation and delivery of regulatory submissions (in the clinical, initial marketing, or post-approval phase)
Lead the review and ensure accurate submissions to Health Authorities
Write and review regional and global CMC submission documents and responses
Manage CMC aspects of routine and non-routine Health Authority interactions
Monitor regulatory CMC environment changes to support CMC global lead and teams
Provide input into regulatory CMC risk assessments and mitigation plans
Coordinate and complete regulatory assessments of CMC changes
Assume responsibilities from the Global Regulatory Lead as delegated
Lead or assist in Reg CMC initiatives and development of standards and SOPs
Maintain appropriate records in the designated system for submissions
Qualification
Required
BS Degree in Life Sciences, Engineering, Biotechnology, or relevant Pharmaceutical Science
7+ years of relevant experience in the pharmaceutical industry or regulatory authority CMC review capacity, with a minimum of 3 years of experience in Regulatory CMC
Proven experience authoring and contributing to CMC submission documents for development and marketed products
Broad registration experience in the pharmaceutical industry or a regulatory authority
Direct communication and negotiation experience with regulatory agencies on CMC matters
Knowledge of GMP requirements and standard systems
Demonstrated competence in leading cross-functional teams
Ability to work independently and within project teams
Demonstrated inclusive leadership and emotional intelligence
Strategic thinking and risk assessment skills
Proven project management abilities across global locations and time zones
Preferred
Graduate degree
Recognized experience in project and timeline management
Experience with clinical development and associated regulatory CMC submissions
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
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