---
title: 'Senior Director, Regulatory Affairs at Annexon Biosciences'
canonical: 'https://feeny.ai/job/senior-director-regulatory-affairs-annexon-biosciences-san-francisco-b2av8f6dqd9f'
type: 'job'
last_seen: '2026-09-13'
---

# Senior Director, Regulatory Affairs at Annexon Biosciences

- **Company:** Annexon Biosciences
- **Location:** San Francisco, CA
- **Posted:** 2026-07-09
- **Last confirmed live:** 2026-09-13
- **Apply:** https://job-boards.greenhouse.io/annexonbioscience/jobs/4713673005

## Job description

Company:

At Annexon Biosciences we are a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases of the body, brain, and eye. Our novel scientific approach targets upstream C1q to block the classical complement inflammatory cascade before it starts, and its therapeutic candidates are designed to provide meaningful benefits across multiple autoimmune, neurodegenerative and ophthalmic diseases. With proof-of concept data in Guillain-Barré syndrome, Huntington’s disease and geographic atrophy, we are rigorously advancing our mid-to late-stage clinical trials to bring new potential treatments to patients as quickly as possible. At Annexon, you’ll be part of a team committed to making an impact together.

For more information on Annexon and our pipeline, check out our site [Annexon Biosciences](https://annexonbio.com/) & [Annexon Pipeline](https://annexonbio.com/pipeline/). We trade on Nasdaq under the ticker symbol ANNX and are headquartered in Brisbane, CA.

We're seeking exceptional talent from all backgrounds to fuel our growth. At Annexon, we're building a diverse, equitable, and inclusive workplace. We value unique perspectives and unconventional paths. If you're the best candidate for the job, even if you don't perfectly fit the traditional mold, we encourage you to apply. Learn more about our commitment to diversity, equity, inclusion, and our company [culture](https://annexonbio.com/our-culture/)!

Position:

This role provides global regulatory leadership and direction to support the development, registration, and life-cycle management of innovative programs within the Annexon portfolio. The Senior Director serves as the Regulatory Lead for assigned programs and is a key strategic advisor to executive leadership on regulatory risks, opportunities, and health authority engagement strategies.

Responsibilities include developing and driving regulatory strategies and detailed plans to meet company objectives, participating in program core teams and governance forums, and managing interactions with regulatory agencies to support development and registration strategies. The Senior Director, Regulatory Affairs will oversee the content and preparation of all regulatory documents and submissions related to applicable programs.

Responsibilities include:

- Provides regulatory leadership in support of the development, registration, and life-cycle management of Annexon products by collaborating cross-functionally with Clinical Development, Clinical Operations, Medical Affairs, CMC, and Quality to develop, coordinate, and implement global regulatory strategies and submissions, including CTAs, for new and ongoing clinical studies
- Lead and manage all aspects of major global marketing applications, including BLAs, NDAs, and MAAs as applicable, working with internal cross-functional teams, external consultants, and vendors to drive successful submissions, regulatory review activities, and post-submission commitments
- Provides strategic regulatory direction on programs to support the global regulatory plan, development plans/clinical study designs, risk assessments, critical issue management, and Health Authority interactions. Proactively identifies regulatory risks and develops mitigation strategies to support program objectives
- Lead regulatory planning for major milestones, including INDs, CTAs, Fast Track, Breakthrough Therapy, PRIME, Orphan Drug, etc.
- Lead and manage interactions with FDA, EMA, and other global Health Authorities, including development of regulatory strategies, briefing documents, meeting preparation, meeting leadership, and regulatory correspondence
- Monitor and interpret evolving global regulatory requirements, guidance, and industry trends impacting development, registration, and commercialization activities, and communicate implications to cross-functional stakeholders.
- Manage day to day reports, submissions, requests for Annexon products
- Recruit, mentor, develop, and manage regulatory professionals and consultants to ensure organizational excellence and successful execution of corporate objectives.
- Other duties as required.

Education, Experience, and Skills:

Required:

- PhD/PharmD with 12+ years’ experience in Regulatory Affairs or BS/MS/MSN with 14+ years’ experience.
- Demonstrated experience leading major marketing application submissions (e.g., BLA, NDA, and/or MAA), including regulatory strategy development, submission execution, and regulatory review activities
- Proven ability to influence senior leadership and cross-functional stakeholders through strategic regulatory guidance, effective communication of complex regulatory issues, and proactive risk assessment and mitigation.
- Experience working directly with the FDA and EMA. In-depth knowledge of FDA and EMA regulations and CTD/eCTD requirement
- Excellent regulatory writing and review skills with demonstrated experience authoring and overseeing high-quality regulatory submissions and Health Authority communications.
- Understands the regulatory environment for biotech companies, as well as pharmaceutical industry regulatory affairs best practices to satisfy regulatory requirements.
- Proactive, creative, forward-thinker with the ability to think innovatively about integrated global strategy for regulatory, reimbursement and patient care, while accurately anticipating future consequences and trends. Ability to engage regulators on new approaches and implement new strategies for product regulatory filings.
- Experience supporting development of biologics and/or small molecules, preferably in rare disease, immunology, and/or neuroscience,
- Possesses leadership skills and ability to interact with outside vendors and partner companies.

Salary Range: $265,000 - $285,000

Location: Annexon Biosciences is located in Brisbane, California This role operates under a hybrid work arrangement and requires regular onsite collaboration at our office. Candidates should be located within commuting distance and able to work in the office multiple days each week.

Benefits:

- A stimulating and rewarding workplace includes flexible work schedules, remote opportunities and the ability to achieve a work-life balance.
- Shuttle service from BART, CalTrain and the Ferry.
- Annexon offers a competitive base salary and equity participation, employee stock purchase plan, as well as a comprehensive health benefit package that includes medical, dental, vision, 401(k), flexible spending plans, and other benefits.

Annexon Biosciences is an Equal Opportunity Employer, and we prohibit discrimination or harassment of any kind.  We are committed to fostering an environment where ALL people are welcome and supported. We cultivate a culture of inclusion for all employees that respects their individual strengths, views, and experiences. We believe that our differences enable us to be a better team – one that makes better decisions, drives innovation, and delivers better business results. Creativity and innovation flourish in an environment of openness, inclusion, and mutual respect.

## About Annexon Biosciences

## Company Overview
- **One-liner**: Annexon Biosciences is a clinical-stage biopharmaceutical company pioneering the development of C1q inhibitors to stop classical complement-mediated neuroinflammation in autoimmune, neurodegenerative, and ophthalmic diseases.
- **Entity Type**: Public (Nasdaq: ANNX)
- **Headquarters**: Brisbane, California, USA
- **Founded**: 2007
- **Founders**: Dr. Ben Barres (co‑founder, deceased) and Dr. Arnon Rosenthal

## Core Business
- **Industry**: Biopharmaceuticals – complement‑targeted therapeutics
- **Target Customers**: Patients and healthcare providers treating classical complement‑mediated diseases (body, brain, eye); B2B partnerships with clinical sites and payers
- **Mission**: “Deliver game‑changing therapies to patients so that they can live their best lives” [annexonbio.com](https://annexonbio.com/about/)

## Products & Services
Annexon’s pipeline is based on inhibiting C1q, the initiating molecule of the classical complement pathway. Key investigational candidates:
- **ANX005**: A monoclonal antibody targeting C1q for intravenous administration. Lead indication is Guillain‑Barré Syndrome (GBS); completed enrollment in a Phase 3 pivotal program – the first such program in GBS in 40 years – and has Orphan Drug Designation from the EMA [annexonbio.com](https://annexonbio.com/about/)
- **ANX007**: An intravitreal antibody fragment targeting C1q for ophthalmic use. Demonstrated statistically significant, dose‑dependent preservation of visual function in a Phase 2 trial in geographic atrophy (GA) [annexonbio.com](https://annexonbio.com/about/)
- **ANX009**: A subcutaneous formulation of ANX005 designed for chronic autoimmune and neurodegenerative indications. Achieved full target engagement in the blood compartment in a Phase 1 healthy volunteer study [annexonbio.com](https://annexonbio.com/about/)
- **ANX1502**: An oral small‑molecule inhibitor of the classical complement pathway. Achieved target pharmacokinetics in a Phase 1 healthy volunteer study [annexonbio.com](https://annexonbio.com/about/)

## Market Standing
- **Valuation / Market Cap**: Not publicly available from provided sources (public company, market cap fluctuates)
- **Key Metric**: Publicly traded (Nasdaq: ANNX); recent major milestones include Phase 3 completion for ANX005 in GBS and Phase 2 data for ANX007 in GA
- **Notable Investors / Partners**: Leaders on board and scientific advisory board include Stephen Hauser (MD, UCSF), Beth Stevens (PhD, Harvard), David Holtzman (MD, Washington University), and others. The co‑founder Dr. Ben Barres was a highly respected neuroscientist [annexonbio.com](https://annexonbio.com/about/)
- **Growth Signals**: Initial public offering in 2020 funded pipeline expansion; active recruiting for senior clinical and medical affairs roles (Senior Director, Clinical Development; VP, Drug Safety; etc.) suggests advancement toward late‑stage trials and potential commercialization [greenhouse.io](https://job-boards.greenhouse.io/annexonbioscience)

## Competitive Advantages
- **First‑in‑class C1q inhibitor focus**: By targeting the top of the classical complement pathway, Annexon aims to block all downstream damaging components rather than a single downstream effector.
- **Broad pipeline across three therapeutic areas** (autoimmunity, neurodegeneration, ophthalmology) targeting nearly 10 million patients worldwide.
- **Biomarker‑driven, disciplined strategy** to improve probability of technical success and deliver precision medicine [ir.annexonbio.com](https://ir.annexonbio.com/corporate-profile)
- **Strong scientific foundation** built on decades of research by co‑founder Dr. Ben Barres on C1q’s role in synapse loss.

## Strategic Focus
- Completing the first Phase 3 program for GBS in 40 years (ANX005) and preparing for regulatory submissions.
- Advancing ANX007 through pivotal trials for geographic atrophy and exploring glaucoma.
- Developing subcutaneous and oral formulations (ANX009, ANX1502) to expand into chronic, less invasive treatment paradigms.
- Employing precision‑medicine biomarkers to identify patients most likely to benefit from classical complement inhibition.

## Why Work Here
- **Culture**: Described as “show up with your heart and mind … team‑based, follow the science.” Core values include warrior spirit, all‑for‑one teamwork, sound judgment, passion, and a thrive mentality [annexonbio.com/careers](https://annexonbio.com/careers/)
- **Work Environment**: Flexible work schedules, remote opportunities, and a Brisbane, CA office with shuttle service from BART, CalTrain, and the Ferry [annexonbio.com/careers](https://annexonbio.com/careers/)
- **Benefits**: Competitive base salary, equity participation, employee stock purchase plan (ESPP), medical/dental/vision insurance, 401(k), flexible spending plans, and a focus on work‑life balance [annexonbio.com/careers](https://annexonbio.com/careers/)
- **Team**: About 4 open positions as of mid‑2026 (Senior Director Clinical Development, VP Drug Safety, etc.) – a small, driven team where contributions are visible and valued [greenhouse.io](https://job-boards.greenhouse.io/annexonbioscience)

## Sources
1. [annexonbio.com – Home](https://annexonbio.com/)
2. [ir.annexonbio.com – Corporate Profile](https://ir.annexonbio.com/corporate-profile)
3. [annexonbio.com – About (Leadership, History, Mission)](https://annexonbio.com/about/)
4. [annexonbio.com – Careers (Culture, Benefits, Values)](https://annexonbio.com/careers/)
5. [greenhouse.io – Jobs at Annexon Biosciences](https://job-boards.greenhouse.io/annexonbioscience)

## Other roles at Annexon Biosciences

- [Senior Director, Global Scientific Communications](https://feeny.ai/job/senior-director-global-scientific-communications-annexon-biosciences-san-ygq0cdyxzd03) — San Francisco, CA
- [Executive Director & Head Clinical Data Management](https://feeny.ai/job/executive-director-head-clinical-data-management-annexon-biosciences-san-srwq0ehec0wz) — San Francisco, CA
- [Field Medical Director (MSL) – Ophthalmology (Southeast Region)](https://feeny.ai/job/field-medical-director-msl-ophthalmology-southeast-region-annexon-biosciences-f7eyw4qqefam) — San Francisco, CA
- [Senior Director, Medical Writing](https://feeny.ai/job/senior-director-medical-writing-annexon-biosciences-san-francisco-kxv9t4ghnxry) — San Francisco, CA
- [Associate Director, Clinical Trial Management](https://feeny.ai/job/associate-director-clinical-trial-management-annexon-biosciences-san-francisco-h3rh38k6a3ek) — San Francisco, CA
- [Senior Director, Drug Safety and Pharmacovigilance](https://feeny.ai/job/senior-director-drug-safety-and-pharmacovigilance-annexon-biosciences-san-w7jhxhsm0t09) — San Francisco, CA
- [Vice President, Medical Affairs-Neuroscience](https://feeny.ai/job/vice-president-medical-affairs-neuroscience-annexon-biosciences-san-francisco-vec8c090165d) — San Francisco, CA
- [Vice President, Clinical Development-Ophthalmology](https://feeny.ai/job/vice-president-clinical-development-ophthalmology-annexon-biosciences-san-8j8gnj3vpggn) — San Francisco, CA
- [Vice President, Medical Affairs-Ophthalmology](https://feeny.ai/job/vice-president-medical-affairs-ophthalmology-annexon-biosciences-san-francisco-4k8s7zf170d6) — San Francisco, CA
- [Senior Director, Regulatory Affairs](https://feeny.ai/job/senior-director-regulatory-affairs-summit-therapeutics-united-states-t8mj3aqfkbgx) — United States