Sr Manager, Global Regulatory Affairs, WCH at Biogen in San Francisco, CA

Job description

About This Role The Sr. Manager, Global Regulatory Affairs (GRA) supports the regulatory strategy and execution for assigned programs, working closely with the Global Regulatory Lead (GRL) and cross-functional teams. This role contributes to the development and implementation of regulatory submissions across multiple regions, ensuring alignment with global regulatory requirements and timelines. The Manager also serves as a key point of contact for regulatory operations and external partners (e.g., CROs), and provides backup support for regulatory activities within the team. What You'll Do Collaborate with the Global Regulatory Lead 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. Who You Are: You are a hands-on Global Regulatory Affairs professional with experience managing and supporting IND, CTA, NDA, and BLA submissions across multiple regions and working directly with health authorities and cross-functional development teams. You thrive in a fast-paced biotech environment, bringing strong regulatory execution, project management, and submission expertise to drive programs forward while ensuring global regulatory compliance. Required Skills 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 (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 Skills Management of CTA Supporting BLA Job Level: Management Additional Information The base compensation range for this role is: $140,000.00-$187,250.00 Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity. Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance. In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being ; including, but not limited to: 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 shut