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 & Annexon 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!

Position:

This role provides global regulatory leadership and direction to support the development, registration, and life-cycle management of innovative and novel programs within the Annexon portfolio. Responsibilities include developing regulatory strategies and detailed plans to meet company objectives, participating in program core teams and governance forums, and managing interactions with global regulatory agencies to support development and registration strategies. The Vice President, Regulatory Affairs will oversee the content and preparation of all regulatory documents and submissions related to applicable programs. Additionally, this individual will mentor junior members of the regulatory team and anticipate and plan for changes in FDA and EU regulations and requirements.

Responsibilities include:

• Provides regulatory leadership and strategic direction in support of the development, registration, and life-cycle management of Annexon products including collaborating cross-functionally with Clinical Development, Clinical Operations, Medical Affairs, Manufacturing and Quality to define and implement global regulatory strategies for Annexon’s novel assets across IND/CTA, NDA/BLA or MAA filings in US, EU, and other regions.
• Lead the preparation and submission of INDs, CTAs, briefing packages, DSURs, IBs, and marketing applications, including representing Regulatory on Program Core Teams as applicable.
• Serve as primary point of contact for FDA, EMA, PMDA, and other authorities, as required. Manage meetings, negotiations, and correspondence.
• Mentor and develop a small regulatory affairs team, including outside consultants; establish SOPs, regulatory systems, and performance metrics.
• Translate regulatory risks into actionable recommendations for product development and business strategy.
• Maintain knowledge of and monitor changes in current global rules, regulations, and guidance governing drugs and biologics in all phases of development, as well as knowledge of therapeutic area(s)
• Manage regulatory budget and external consultants/CRO relationships, including submission vendors, as required.
• Support due diligence and business development teams on regulatory risk assessments.
• Other duties as required.

Education, Experience, and Skills:

Required:

• PhD/PharmD with 15+ years’ experience in Regulatory Affairs or BS/MS/MSN with 18+ years’ experience.
• Experience in a successful leadership role with a proven track record of regulatory submissions to FDA, EMA, and/or international agencies.
• Experience in working directly with the FDA and EMA. In-depth knowledge of FDA regulations, EMA regulations, and knowledge of CTD/eCTD
• Capable both as a strategic leader and hands on contributor in a fast-paced small company environment.
• Superior scientific writing skills for developing regulatory documents.
• Understands the regulatory environment for pharmaceutical 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 with small and large molecules and rare diseases.
• Develops and maintains strong collaborative internal and external working relationships.
• Possesses a thorough knowledge of current FDA regulations and guidance of requirements for investigational products, IND/NDA submission requirements, and CMC information.
• Must be able to generate regulatory strategies and provide leadership to multidisciplinary teams.
• Possesses leadership skills and ability to interact with outside vendors and partner companies.
• Must be a demonstrated self-starter and team player with strong interpersonal skills.
• Must be a hands-on player.

Preferred:

• Experience within the ophthalmology domain is a plus

Salary Range: $306,000 to $340,000

Location: This is an on-site position located at Annexon Headquarters in Brisbane, California.

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.