Global Regulatory Affairs Lead: Submissions & Strategy

TalentAlly; 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 with gym/3

Paid vacation and year-end shutdown (≥

12 company paid holidays

3 personal days

12 sick time per year

Maternity and Parental Leave

401(k) with company match

Employee stock purchase plan

Tuition reimbursement up to $10,000

Employee Resource Groups

Job summary

Biogen is seeking a Sr. Manager, Global Regulatory Affairs in San Francisco to lead regulatory strategy and execution for assigned programs across regions.

You will coordinate submissions (IND/CTA/NDA/BLA), manage health authority responses, and partner with CROs to ensure on-time delivery and regulatory compliance. You will oversee cross-functional teams, provide leadership in labeling strategy, and maintain systems like GRIT to reflect approvals.

Qualifications

• Bachelor’s degree with 5+ years in regulatory affairs.
• Strong knowledge of global regulatory requirements and guidelines.
• Experience managing submissions across multiple regions (IND/CTA/NDA/BLA).
• Excellent planning, organization, and project management skills.
• Strong written and oral communication for cross-functional updates.
• Proven ability to collaborate across functions and solve problems.
• Experience with regulatory systems such as Veeva Vault, Docubridge, CTIS.
• Ability to work independently in a fast-paced matrix environment.

Responsibilities

• Collaborate with Global Regulatory Lead to support strategy and execution.
• Participate in cross-functional teams for submission planning and labeling strategy.
• Lead or support review of submission packages (INDs, CTAs, NDAs/BLAs).
• 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 implement labeling across functions.
• Maintain regulatory systems to reflect submission approvals for supply release.
• Serve as backup for other regulatory team members during absences.

Skills

Regulatory strategy

Regulatory submissions

Project management

Cross-functional collaboration

Written & verbal communication

Regulatory systems (Veeva Vault)

Independence in fast-paced env.

Education

Bachelor’s degree in life sciences

Tools

Veeva Vault

Docubridge

CTIS

Job description

Biogen is seeking a Sr. Manager, Global Regulatory Affairs in San Francisco to lead regulatory strategy and execution for assigned programs across regions.

You will coordinate submissions (IND/CTA/NDA/BLA), manage health authority responses, and partner with CROs to ensure on-time delivery and regulatory compliance. You will oversee cross-functional teams, provide leadership in labeling strategy, and maintain systems like GRIT to reflect approvals.