Senior Manager, Global Regulatory Affairs

Biogen

. Collaborate with the Global Regulatory Lead to support regulatory strategy and execution for assigned programs .

Posted 10/21/2026full-timeSan Francisco • California • United StatesSenior💰 $140,000 - $187,250 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Expertise in regulatory affairs with a strong understanding of global regulatory requirements and submission processes, including INDs, CTAs, and NDAs/BLAs. Proven ability to manage cross-functional collaboration and maintain regulatory systems effectively.

Highest-signal resume keywords

Regulatory Submission ManagementGlobal Regulatory RequirementsRegulatory Systems ExperienceProject Management SkillsOral And Written Communication

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Submission PackagesINDCTANDABLAHealth Authority Query ResponsesRegulatory StrategyLabeling StrategyRegulatory Guidelines InterpretationRegulatory Affairs

Soft Skills

CollaborationProblem-SolvingPlanningOrganizationCommunication

Tools & Technologies

Veeva VaultDocubridgeCTISGRIT

Industry Keywords

Pharmaceutical IndustryBiotechnology IndustryRegulatory AffairsSubmission LogisticsCross-Functional Teams

Tech Stack

Tools & technologies

Vault

About the role

Key responsibilities & impact

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 such as 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

Requirements

What you’ll need

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

Benefits

Comp & perks

Regular employees are eligible for short-term and long-term incentives, including cash bonus and equity incentive opportunities
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 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