Executive Director/ Senior Director, Regulatory Affairs

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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 & Annexon Pipeline . We trade on Nasdaq under the ticker symbol ANNX and are headquartered in Brisbane, CA.

We seek applicants from all backgrounds to ensure we get the best, most creative talent on our team. We are building a diverse and inclusive workforce - come and be a part of our growth.

At Annexon, we are building a diverse, equitable, inclusive, and innovative company and we are looking for the BEST candidate for the job. That candidate may come from a less traditional background or may meet the qualifications in a different way. We would strongly encourage you to apply - especially if the reason you are the best candidate is not exactly as we describe it here. Learn more about Annexon's commitment to diversity, equity, inclusion, our values and 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. Responsibilities include developing 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 Executive Director/Senior Director, 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 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 develop, coordinate and implement the regulatory strategies and submissions for global CTAs for new and ongoing clinical studies.
• 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. Represents Regulatory on Program Core Teams as applicable.
• Liaise with FDA, EMA and other Regulatory Agencies, as needed.
• Oversee the preparation and submission of assigned sections of filings to regulatory authorities, including, but not limited to, IND, NDA, CTA, MAA applications.
• Lead and manage FDA/EMA meetings, including leading briefing documents and meeting minutes.
• 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 day to day reports, submissions, requests for Annexon products
• Other duties as required.

Education, Experience, and Skills:

• PhD/PharmD with 12+ years' experience in Regulatory Affairs or BS/MS/MSN with 14+ years' experience.
• Experience in a successful leadership role in managing, developing late-stage clinical candidate drugs.
• Experience in working directly with the FDA and EMA. In-depth knowledge of FDA regulations, EMA regulations, and knowledge of CTD/eCTD
• 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. Experience with division of ophthalmology is a plus
• 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.
• Proven track record of successful interaction with the regulatory agencies, as demonstrated by timely submissions and approvals of pharmaceutical products.
• 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.

Salary Range: Sr. Director ($258,000 - $287,00) / Executive Director ($283,000 - $314,000)

Benefits:

• A stimulating and rewarding workplace includes flexible work schedules, remote opportunities and the ability to achieve a work-life balance.
• Our headquarters is in Brisbane, CA, with a 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, as well as 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.

Staffing Agencies: Annexon Biosciences does not accept unsolicited agency resumes and will not pay fees to any third-party agency or firm that doesn't have a signed agreement with Annexon Biosciences. Please do not send agency CVs/resumes through Annexon's website or Annexon Employees. Inquiries must be sent to with the Subject: Staffing Agency Request.

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