Sr Manager, Global Regulatory Affairs, WCH

Biogen•San Francisco, CA

13d

About The Position

The Sr. Manager, Global Regulatory Affairs supports regulatory strategy and execution for assigned programs in close collaboration with the Global Regulatory Lead and cross-functional teams. The role contributes to developing and implementing regulatory submissions across multiple regions while ensuring alignment with global regulatory requirements and timelines. It serves as a key point of contact for regulatory operations and external partners, such as CROs, and provides backup support for regulatory activities within the team. The position involves participating in cross-functional project teams, reviewing submission packages, managing health authority queries, coordinating submission logistics, supporting US labeling implementation, and maintaining regulatory systems. The role is suited to a hands-on regulatory affairs professional experienced in global submissions and able to contribute independently in a fast-paced, matrixed biotech environment.

Requirements

Bachelor’s degree with 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, including IND, CTA, and 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 Global Regulatory Lead to support regulatory strategy and execution for assigned programs.
Participate in cross-functional project teams, provide regulatory input, and align on submission planning and labeling strategy.
Lead or support 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, such as GRIT, to reflect submission approvals related to supply release.
Serve as backup for other regulatory team members during absences to ensure continuity of regulatory support.

Benefits

Medical, dental, vision, and life insurance.
Fitness and wellness programs, including fitness reimbursement.
Short- and long-term disability insurance.
A minimum of 15 days of paid vacation and end-of-year shutdown time off from December 26 through December 31.
Up to 12 company-paid holidays and 3 paid days off for Personal Significance.
80 hours of sick time per calendar year.
Paid maternity and parental leave.
401(k) program with company-matched contributions.
Employee stock purchase plan.
Tuition reimbursement of up to $10,000 per calendar year.
Employee Resource Groups participation.
Short-term and long-term incentives, including cash bonus and equity incentive opportunities, for eligible regular employees.