Regulatory Affairs Manager

Role Summary

The Manager, Regulatory Affairs is based in San Diego, California and will be responsible for supporting regulatory strategy implementation for development programs. Works closely with the Executive Director, Regulatory Affairs to prepare regulatory submissions (authoring, timeline planning, etc.), to support regulatory and clinical objectives. Assists in developing and implementing global regulatory strategies and in the establishment and maintenance of department regulatory processes. The role involves developing collaborative partnerships internally and externally with contract research organizations, electronic publishing, and other vendors as required.

Responsibilities

• Actively participate as a member of Regulatory Affairs teams and on cross-functional product development teams as needed.
• Act as a regulatory lead on a Phase 1, 2 or 3 clinical study.
• Contribute to developing and implementing regulatory strategies for global submissions from early R&D through commercialization.
• Support the compilation, review and/or filing of INDs, CTAs, briefing documents and maintenance of development and approved applications.
• Coordinate and contribute to the authoring of submission documents such as DSURs, annual reports, routine submissions, and amendments as needed.
• Develop and manage project timelines for regulatory submissions.
• Maintain effective interactions with all contributors and Regulatory Affairs management, to ensure timely delivery of documents for regulatory submissions.
• Provide regulatory assistance and review of clinical study documentation, including review of clinical protocols, informed consent documents, clinical study recruitment materials, and essential document packages.
• Track submissions, correspondence, and commitments with health authorities.
• Provide guidance to project teams to ensure regulatory documentation is complete, accurate, of high quality and electronically functional.
• Write and/or maintain standard operating procedures, department working practices, templates and style guides, as appropriate.
• Conduct regulatory intelligence or research projects as required.

Qualifications

• Required: Bachelor’s or M.S./Ph.D. degree in scientific area.
• Required: Minimum of 7 years’ experience with a Bachelor’s or 5 years’ experience with M.S./Ph.D. of relevant Regulatory Affairs experience in a biotech/pharmaceutical setting.
• Required: Minimum of 2 years supervisory experience.
• Required: Equivalent combination of relevant education and applicable job experience may be considered.
• Required: Experience and understanding of ICH, GCP requirements, and FDA regulations; experience with preparation of regulatory submissions (US IND and/or NDA sequences).
• Required: Ability to work independently and within project teams to see projects through to completion.
• Required: Excellent written and oral communication skills; strong organizational and interpersonal skills; ability to meet deadlines in a fast-paced setting.
• Required: Software Knowledge: Windows, MS Office; advanced MS Word and Adobe PDF knowledge.
• Preferred: Additional experience with Clinical Trial Authorizations (CTA) and Marketing Authorization Applications (MAA).
• Preferred: Experience interpreting and applying local regulations and guidance for drug development from early R&D through commercialization.
• Preferred: Experience with electronic document management systems (e.g., Veeva) and publishing/eCTD tools (Lorenz, GlobalSubmit, eCTDExpress, etc.).

Education

• Bachelor’s or M.S./Ph.D. degree in a scientific field.

Additional Requirements

• Travel: Travel may be required up to 5% of time.
• Physical Demands: Sit for extended periods; some walking and lifting up to 25 lbs may be required; normal office environment.