Senior Global Regulatory Strategy Lead

Biogen, Inc.; 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 including,

Short- and Long-Term Disability

15 days paid vacation + shutdown Dec /

12 company holidays + 3 personal days

401(k) with company match

Employee stock purchase plan

Tuition reimbursement up to $10,000

Employee Resource Groups

Job summary

Biogen, Inc. is seeking a Sr. Manager, Global Regulatory Affairs to help shape regulatory strategy and lead submissions across INDs, CTAs, NDAs and BLAs.

You will partner with GRL and cross-functional teams to ensure compliance with global regulatory requirements and timelines, and to manage interactions with health authorities and CROs. In this fast-paced biotech environment, you will oversee submission planning, labeling strategy, and regulatory operations, while mentoring junior staff and

Qualifications

• Bachelor's degree required with 5+ years in regulatory affairs in pharma/biotech.
• Strong understanding of global regulatory requirements and policy statements.
• Experience managing regulatory submissions across multiple regions and submission types (IND, CTA, NDA/BLA).

Responsibilities

• 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.

Skills

Regulatory strategy

IND/CTA/NDA/BLA submissions

Cross-functional teamwork

Regulatory submissions across regions

Project management

Communication skills

Regulatory systems

Education

Bachelor's degree in life sciences

Tools

Veeva Vault

Docubridge

CTIS

Job description

Biogen, Inc. is seeking a Sr. Manager, Global Regulatory Affairs to help shape regulatory strategy and lead submissions across INDs, CTAs, NDAs and BLAs.

You will partner with GRL and cross-functional teams to ensure compliance with global regulatory requirements and timelines, and to manage interactions with health authorities and CROs. In this fast-paced biotech environment, you will oversee submission planning, labeling strategy, and regulatory operations, while mentoring junior staff and