Senior Global Regulatory Affairs Manager - Submissions

Biogen; San Francisco (CA); On-site; USD 140,000 - 187,000; Full time

Benefits offered by this job

Medical, Dental, Vision, & Life ins.

Fitness & Wellness programs

Vacation and holidays

401(k) with company match

Employee stock purchase plan

Tuition reimbursement

Job summary

Biogen is seeking a Sr. Manager, Global Regulatory Affairs to drive regulatory strategy and execution for complex programs. You will collaborate with the GRL and cross-functional teams to prepare filings across IND, CTA, NDA/BLA types and manage health authority interactions.

The role requires 5+ years in regulatory affairs, strong global regulatory knowledge, and experience with major submission types. A fast-paced biotech environment and leadership responsibilities define this management

Qualifications

• Bachelor’s degree with 5+ years of experience in regulatory affairs.
• Strong knowledge of global regulatory requirements, guidelines, and policy statements.
• Demonstrated ability to manage regulatory submissions across multiple regions and submission types (IND, CTA, NDA/BLA).
• Excellent planning, organization, and project management skills.
• Strong written and spoken communication skills for cross-functional teams.
• Proven ability to build collaborative relationships across functions and problem-solve.

Responsibilities

• Support regulatory strategy and execution for assigned programs with GRL and cross-functional teams.
• Lead or support regulatory submission package reviews (INDs, CTAs, NDAs/BLAs, and supplements).
• Manage health authority query responses with timely, accurate communication.
• Coordinate with Regulatory Operations and CROs for submission logistics.
• Provide guidance on US labeling precedence and implementation across functions.
• Maintain regulatory systems to reflect submission approvals related to supply release.
• Serve as backup for other regulatory team members during absences.

Skills

Regulatory submissions

Cross-functional collaboration

Regulatory strategy

Labeling strategy

IND/CTA/NDA/BLA submissions

Project management

Communication skills

Regulatory systems interaction

Education

Bachelor’s degree in life sciences

Tools

Veeva Vault

Docubridge

CTIS

Job description

Biogen is seeking a Sr. Manager, Global Regulatory Affairs to drive regulatory strategy and execution for complex programs. You will collaborate with the GRL and cross-functional teams to prepare filings across IND, CTA, NDA/BLA types and manage health authority interactions.

The role requires 5+ years in regulatory affairs, strong global regulatory knowledge, and experience with major submission types. A fast-paced biotech environment and leadership responsibilities define this management