Regulatory Affairs Director
4 days ago
At Annexon Biosciences, we are seeking a highly skilled and experienced Director, Regulatory Affairs to join our team. As a key member of our regulatory affairs department, you will be responsible for managing regulatory activities that support our department and company projects and programs.
Key Responsibilities:- Develop, coordinate, and execute regulatory strategies for new product development registrations.
- Collaborate with internal stakeholders to generate regulatory submission plans and direct document development, review, and finalization.
- Prepare and submit all sections of all 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 with minimal supervision.
- Obtain approval, including negotiation with regulators in the US and ROW, with minimal supervision.
- 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.
- 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.
- Proven success in regulatory agency interactions, ensuring timely submissions, approvals, and effective management of submission timelines.
- Leadership skills and ability to interact with senior management, and to work with outside vendors and partner companies.
- International regulatory experience (e.g., EU and/or Canada).
- A stimulating and rewarding workplace with flexible work schedules, remote opportunities, and the ability to achieve a work-life balance.
- 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, 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.
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Brisbane, California, United States Mammoth Biosciences Full time{"title": "Regulatory Affairs Director", "content": "Lead Regulatory Affairs for Therapeutic ProgramsMammoth Biosciences is seeking a highly experienced Regulatory Affairs Director to lead the regulatory activities of our growing CRISPR-based therapeutic programs. This role will be responsible for coordinating all aspects of regulatory strategy,...
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