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:

The Director, Regulatory Affairs is primarily responsible for managing regulatory activities that support the department and Annexon's projects and programs. This position will assist with leading, developing, coordinating and executing regulatory strategies for new product development registrations. The individual is responsible for resolving discrepancies between products and regulatory standards, while proactively anticipating and preparing for changes in FDA and EU regulations and requirements.

Responsibilities include:

• Collaborate with internal stakeholders to develop, coordinate and execute the regulatory strategies for new product development registrations.
• Work with development teams to execute strategies for regulatory submissions. Generate regulatory submission plans, and direct document development, review, and finalization.
• Preparation and submission of all sections of all filings to regulatory authorities, including, but not limited to, IND, NDA, CTA and MAA applications.
• Provide leadership in creating and executing proactive global regulatory strategies for product development, approval and registration, and support of future programs.
• Lead global regulatory submission preparations per plan with minimal to no supervision.
• Responsible for obtaining approval including negotiation with the regulators in US and ROW with minimum to no supervision.
• Proactively build relationships and trust with key internal and external stakeholders and decision makers.
• Manage relationship with external consultants/CROs supporting development of study start up.
• Develop and implement regulatory strategies, including regulatory risk management, ensuring that any RA issues are highlighted and addressed satisfactorily and in a timely fashion.
• Participate as an active, engaged global team member on core projects and/or provide RA guidance/strategy to Core team members.
• Other tasks as needed to support the Regulatory group.

Education, Experience, and Skills:

Required:

• PhD/PharmD with 7+ years' experience in Regulatory Affairs or BS/MS with 10+ years' experience
• Has primary responsibility for coordinating the preparation of drafts, edits, review and submission of regulatory dossiers in support of investigational and new drug applications
• Superior scientific writing skills for developing regulatory documents
• Possesses in depth knowledge of FDA regulations, including CTD/eCTD, and requirements for investigational products, IND and BLA submissions, with direct experience working with FDA
• Supports the department in generating regulatory strategies, providing leadership to multidisciplinary teams, while working with project teams and management to identify regulatory risks and ensure the earliest possible arrival
• Proven success in regulatory agency interactions, ensuring timely submissions, approvals and effective management of submission timelines
• Possesses leadership skills and ability to interact with senior management, and to work 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:

• International regulatory experience (e.g., EU and/or Canada)

Salary Range: $222,000 to $248,000

Benefits:

• A stimulating and rewarding workplace includes flexible work schedules, remote opportunities and the ability to achieve a work-life balance.
• We are located in Brisbane, CA, with 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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