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New · posted Oct 22

Biogen · Biotechnology

Sr Manager, Global Regulatory Affairs

  • San Francisco, CA
  • On-site
  • Full-time
  • Manager
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Pay$140K–$187Ka year · employer provided
EmploymentFull-time
LocationSan Francisco, CAOn-site
LevelManager
FunctionRegulatory AffairsRegulatory
Deadline

Open until filled

The 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 need

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

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.

Preferred Skillsnice to have

  • Management of CTA
  • Supporting BLA

Job Level: Management

Skills named in this posting

What you'll do

  1. Collaborate with the Global Regulatory Lead to support regulatory strategy and execution for assigned programs.
  1. Participate in cross-functional project teams to provide regulatory input and ensure alignment on submission planning and labeling strategy.
  1. Lead or support the review of regulatory submission packages, including INDs, CTAs, NDAs/BLAs, and supplemental submissions.
  1. Manage health authority query responses, ensuring timely and accurate communication and resolution.
  1. Coordinate with Regulatory Operations and CROs to facilitate submission logistics and document delivery.
  1. Provide guidance on US labeling precedence and support implementation of US labeling across functions.
  1. Maintain and update regulatory systems (e.g., GRIT) to reflect submission approvals related to supply release.
  1. Serve as a backup for other regulatory team members during absences, ensuring continuity of regulatory support.

Pay and benefits

$140,000 – $187,250 a year

Employer provided
How this compares

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 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

  • Medical, dental, vision and life insurance

  • 401(k) with company match

  • Employee stock purchase plan

  • 15+ days paid vacation and 12 paid holidays

  • Paid maternity and parental leave

  • Tuition reimbursement up to $10,000 per year

Where you'll work

San Francisco, CAOn-siteOpen in Maps (opens in a new tab)

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From the posting

About Biogen

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about Biogen.

Biogen company page · 11 open roles
Equal opportunity, accessibility and legal noticesBiogen's statements, word for word

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.

Job intelligence

The context around this role

Live data · October 23, 2026

Salary intelligence

How the pay compares

This role's midpoint is 1% above the US median for Regulatory Affairs roles at this level.

This roleEmployer provided

$140,000 to $187,250 a year

Manager roles in California16 roles publishing pay

Middle half $161,375 to $181,000, median $171,000

Manager roles in the US54 roles publishing pay

Middle half $147,875 to $174,625, median $161,250
Annual base pay
Annual base payLowMedianHigh
This role$140,000—$187,250
California$161,375$171,000$181,000
All US$147,875$161,250$174,625

This role: Biogen's own published range. Comparisons: the base pay employers published on open Regulatory Affairs roles at the same level on Regulatory Jobs, October 23, 2026. Nothing is estimated.

Career trajectory

Where this role sits in Regulatory Affairs

The general path across 315 open Regulatory Affairs roles on Regulatory Jobs, with the titles they carry most. Not Biogen's own promotion track.

  1. Earlier

    Associate & Specialist

    Often: Regulatory Affairs Specialist · Summer 2027 Internship

    $92K median39 open

  2. One step back

    Senior & Principal

    Often: Senior Regulatory Affairs Specialist · Principal Regulatory Affairs Specialist

    $138K median75 open

  3. This role

    Manager

    Often: Regulatory Affairs Manager · Manager, Regulatory Affairs

    $161K median68 open

  4. Next step

    Director

    Often: Senior Director, Regulatory Affairs · Director, Regulatory Affairs

    $236K median116 open

  5. Later

    VP & Executive

    Often: Global Head of Injectable Aesthetics Regulatory Strategy · Global Head of Regulatory Affairs, Roche Diagnostics

    $323K median17 open

Career resources on Regulatory Affairs

Skills DNA

What this role leans on

How many of the posting's 21 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.

GMP and compliance: 2 linesDocumentation and SOPs: 1 lineRegulatory submissions: 11 linesData and digital systems: 1 lineCollaboration and leadership: 10 linesGMPDocumentationSubmissionsData systemsTeamwork
  • Regulatory submissions11
  • Collaboration and leadership10
  • GMP and compliance2
  • Documentation and SOPs1
  • Data and digital systems1

Regulatory intelligence

The rules behind this role

Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.

From Regulatory News

Manufacturing and quality coverage for this profession

Company hiring pulse

Biogen on Regulatory Jobs

11
Open roles
11
Distinct roles
4
Locations

By discipline

  • Quality7 64%
  • Regulatory4 36%

By level

  • Senior & Principal4 36%
  • VP & Executive3 27%
  • Director2 18%
See all 11 Biogen roles

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Sr Manager, Global Regulatory Affairs at Biogen

Open until filled. $140K–$187K a year, employer provided.

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