Sr. Manager, Regulatory Affairs
About The Position
The Senior Manager, Regulatory Affairs is a senior individual contributor who supports regulatory strategy execution for assigned clinical-stage cell and gene therapy programs. As a recognized regulatory subject matter expert, this role evaluates complex and evolving requirements, establishes regulatory approaches, and communicates program decisions. The position collaborates closely with regulatory operations, quality, CMC, nonclinical, and clinical colleagues to support high-quality, timely regulatory submissions. It supports execution and may lead submissions and coordinate health authority interactions, aligning internal and external stakeholders while maintaining compliance with applicable regulations. This is a hybrid role, preferably for candidates near the San Diego area, with up to 10% travel. The role supports regulatory submissions and strategic planning for assigned programs; prepares, creates, assembles, reviews, and archives complex submissions; manages submission timelines; and coordinates with internal and CRO teams. It ensures submission accuracy, completeness, and consistency, maintains health authority correspondence archives, reviews essential document packages, and supports site start-up from a regulatory perspective. The position also tracks regulatory intelligence, contributes to SOP development and review, promotes quality and continuous improvement, and supports cross-functional initiatives and other assigned duties.
Requirements
- Experience preparing regulatory submissions, such as INDs, DSURs, CTAs, and FDA meeting requests.
- Strong communication, interpersonal, and collaboration skills with internal and external stakeholders.
- Good project management skills, including the ability to manage multiple projects simultaneously and meet deadlines.
- High attention to detail and excellent problem-solving and analytical thinking abilities.
- Excellent writing and editorial skills, including the ability to develop clinical-regulatory documents such as investigator brochures, briefing documents, IND amendments, and Fast Track/ODD designation requests.
- Strong scientific background and ability to quickly acquire knowledge in therapeutic areas and the evolving regulatory landscape.
- Familiarity with global regulatory requirements and FDA and ICH guidelines, and ability to gather and analyze current regulatory intelligence.
- Proficiency with Microsoft Office Suite, including Word, Excel, and PowerPoint.
- Bachelor's degree in Life Sciences, Pharmacy, Engineering, or a related scientific discipline.
- At least 6 years of progressively responsible regulatory affairs experience within biotechnology, cell therapy, pharmaceuticals, medical device, or related industries.
- Strong computer skills, including Microsoft Office Suite and Adobe Acrobat.
Nice To Haves
- Advanced degree.
- Experience with a regulatory information management system such as Veeva RIM.
- Broad understanding of international GXP regulations, guidelines, processes, publishing standards, and issues in drug or biologics development.
Responsibilities
- Support regulatory submissions and contribute to strategic planning for assigned programs.
- Prepare, create, assemble, review, and archive complex regulatory submissions in compliance with applicable requirements, coordinating with internal and CRO teams.
- Develop, manage, and track regulatory submission timelines.
- Collaborate with regulatory operations, quality, CMC, nonclinical, and clinical teams.
- Ensure submissions meet accuracy, completeness, and consistency standards, and maintain health authority correspondence archives.
- Review essential document packages and support site start-up activities from a regulatory perspective.
- Analyze current regulatory issues, guidance, and initiatives, and communicate regulatory intelligence internally.
- Contribute to developing and reviewing standard operating procedures to ensure regulatory compliance.
- Perform duties in keeping with company core values, policies, and applicable regulations.
- Promote a culture of quality and continuous improvement across the organization.
- Support cross-functional initiatives and continuous improvement efforts.
- Perform additional duties as assigned.
- Travel up to 10%.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
