The Senior Manager, Regulatory Affairs is a senior individual contributor who supports regulatory strategy execution for assigned clinical-stage cell and gene therapy programs. Serving as a recognized regulatory subject matter expert, this role collaborates and evaluates complex and evolving requirements, establishes regulatory approaches, and communicates program decisions. This role collaborates closely with colleagues across regulatory operations, quality, CMC, nonclinical, and clinical functions to support high-quality, timely regulatory submissions. The position supports execution and may lead submissions and coordinate health authority interactions, driving alignment among internal and external stakeholders while maintaining compliance with applicable regulations. This position is a hybrid role, preferably with candidates near the San Diego area.
DUTIES AND RESPONSIBILITIES:
- Support regulatory submissions and contribute to strategic planning for assigned programs.
- Prepare and deliver high-quality and timely regulatory submissions in compliance with applicable regulatory requirements.
- Responsible for the creation, assembly, review, and archival of complex regulatory submissions which require interaction with internal and CRO teams to ensure optimal execution.
- Develop, manage and track regulatory submission timelines.
- Collaborate cross-functionally with regulatory operations, quality, CMC, nonclinical, clinical teams.
- Ensure submissions meet standards for accuracy, completeness, and consistency, and maintain health authority correspondence archives.
- Review essential document packages and support site start-up activities from regulatory perspective.
- Expand knowledge by analyzing current regulatory issues, guidance, initiatives and effectively communicate regulatory intelligence internally.
- Contribute to the development and review of standard operating procedures to ensure regulatory compliance.
- Perform all duties in keeping with the Company's core values, policies and all 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.
- Up to 10% travel.
JOB SPECIFICATIONS:
- Experience in preparing regulatory submissions (e.g., IND, DSUR, CTA, FDA meeting requests).
- Strong communication, interpersonal, and collaboration skills across internal and external stakeholders.
- Good project management skills; able to manage multiple projects simultaneously and meet deadlines.
- High attention to detail, with excellent problem-solving and analytical thinking abilities.
- Excellent writing and editorial skills, with the ability to develop high-quality clinical-regulatory documents (e.g., investigator brochures, briefing documents, IND amendments, Fast Track/ODD designation requests).
- A strong scientific background with the ability to quickly acquire knowledge in the therapeutic areas and the evolving regulatory landscape.
- Familiarity with global regulatory requirements and guidelines (FDA, ICH), with the ability to gather and analyze latest regulatory intelligence and motivated to learn new things.
- Computer expertise, including Microsoft Office Suite proficiency (eg, Word, Excel, PowerPoint). Experience with regulatory information management system (Veeva RIM) is a plus.
EDUCATION AND EXPERIENCE:
- Bachelor's degree in Life Sciences, Pharmacy, Engineering, or a related scientific discipline required; advanced degree preferred.
- Minimum of 6-8 years of progressively responsible regulatory affairs experience within biotechnology, cell therapy, pharmaceuticals, medical device, or related industries
- Broad understanding of international GXP regulations, guidelines, processes, publishing standards, and issues in drug/biologics development is strongly preferred.
- Strong computer skills, including Microsoft Office Suite (Word, PowerPoint, and Excel) and Adobe Acrobat.
WORKING CONDITIONS
General Office Environment. This is an indoor position that requires sitting at a desk for extended periods of time and the ability to type and use a computer. The noise level in the work environment is usually quiet to moderate.
PHYSICAL DEMANDS
While performing the duties of this Job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms and talk or hear. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
These work environment characteristics are representative of the environment the job holder will encounter. Reasonable accommodations may be made to enable people with disabilities to perform the essential functions of the job.