Senior Manager, Regulatory CMC Lead
About The Position
About This Role: As a Senior Manager, Regulatory CMC Lead, you will provide regulatory CMC expertise to support assigned projects and products, contribute to global CMC regulatory strategy, and where appropriate, lead regulatory submissions and related strategic activities. You will be part of a dynamic team, collaborating closely with the CMC Global Regulatory Lead and key stakeholders to compile and prepare submissions/documentation for biologics projects. Your role will involve managing routine and non-routine regional Health Authority interactions, serving as the primary global contact for regulatory CMC activities. In late-stage development programs, you will be the contact for assigned regions, ensuring seamless communication and execution of the regulatory CMC strategy. This position is vital to the success of our business, as it ensures compliance and facilitates the advancement of our projects within the regulatory framework. This is a hybrid role based in our office in San Francisco, CA (Biogen West Coast Hub).
Requirements
- 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.
Nice To Haves
- Graduate degree
- Recognized experience in project and timeline management.
- Experience with clinical development and associated regulatory CMC submissions.
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.
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
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Number of Employees
5,001-10,000 employees
