Director, Regulatory Affairs

$222,000 - $248,000/Yr

Annexon Biosciences - Brisbane, CA

Full-time - Director

Brisbane, CA

Professional, Scientific, and Technical Services

About the position

The Director, Regulatory Affairs at Annexon Biosciences is responsible for managing regulatory activities that support the company's projects and programs. This role involves leading the development and execution of regulatory strategies for new product registrations, ensuring compliance with FDA and EU regulations, and fostering relationships with internal and external stakeholders to facilitate successful regulatory submissions.

Responsibilities

• Collaborate with internal stakeholders to develop, coordinate and execute regulatory strategies for new product development registrations.
• Work with development teams to execute strategies for regulatory submissions, generating regulatory submission plans and directing document development, review, and finalization.
• Prepare and submit all sections of filings to regulatory authorities, including IND, NDA, CTA, and MAA applications.
• Provide leadership in creating and executing proactive global regulatory strategies for product development, approval, and registration.
• Lead global regulatory submission preparations per plan with minimal to no supervision.
• Obtain approval including negotiation with regulators in the US and ROW with minimal to no supervision.
• Proactively build relationships and trust with key internal and external stakeholders and decision makers.
• Manage relationships 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.

Requirements

• PhD/PharmD with 7+ years' experience in Regulatory Affairs or BS/MS with 10+ years' experience.
• 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.
• 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.
• 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.
• Demonstrated self-starter and team player with strong interpersonal skills.

Nice-to-haves

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

Benefits

• Flexible work schedules
• Remote opportunities
• Work-life balance
• Shuttle service from BART, CalTrain and the Ferry
• Competitive base salary
• Equity participation
• Employee stock purchase plan
• Comprehensive health benefit package including medical, dental, vision, 401(k), flexible spending plans