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The job details are as follows:The Regulatory Affairs Manager will manage and lead the preparation, compilation, and review of regulatory submissions and related CMC and labeling documents pertaining to US, EU, and ROW for assigned projects. This role will collaborate with the manager, project teams, and functional area representatives to devise and implement sound regulatory CMC and labeling strategies.
- Manage and lead regulatory CMC activities to meet established timelines and department goals for assigned products and territories, delegating tasks as required
- Manage and lead updates to quality sections of regulatory filings (includes INDs, NDAs, BLAs, etc.) and review of quality submission documents to ensure consistency with related filings and regulatory requirements
- Interact with UT manufacturing and quality groups, contract and partner organizations regarding CMC regulatory issues and provide strategic CMC regulatory interpretation and guidance to project teams
- Actively manage and mentor junior level regulatory personnel as required or applicable. Direct and manage direct reports to include responsibilities for training, goal setting and achievement, performance evaluations/management, coaching, mentoring, career development and provide support for recruitment process (as needed).
- Perform and lead labeling activities as necessary, including editing, review and QC of content and ensuring consistency with regulatory requirements as well as leading internal labeling team meetings
- Work independently on assigned projects using knowledge, experience, data interpretation, analyses, and problem-solving skills for resolution of unprecedented complex CMC issues
- Assist in dossier preparation and provide timely updates for partner organizations in worldwide territories, ensuring accuracy and consistency
- Contribute to other regulatory and compliance activities as required, working closely with project teams and other regulatory personnel
- Implement new technologies, practices, methods, or regulatory agency guidance for applicability to job function
- Perform other duties as assigned
Minimum Requirements
- Bachelor's Degree in a science discipline
- 8+ years of direct experience with a regulatory affairs CMC role with a Bachelor's degree, or
- 6+ years of direct experience with a regulatory affairs CMC role with a Master's degree, or
- 2+ years of direct experience with a regulatory affairs CMC role with PhD or PharmD
- Experience with electronic publishing tools (eCTDs), electronic document management systems, or other specialized software used within the pharmaceutical industry
- Excellent organizational, multitasking, and communication skills
- Strong attention to detail and project completion
- Strong technical knowledge and proficient in use of MS Office suite
- Experience and comfort working independently and as part of a team on multiple projects with ability to prioritize effectively
Preferred Qualifications
- Master's Degree in a science discipline
- Doctor of Philosophy (PhD) or PharmD in a science discipline
- Experience with drug, biologics, and device labeling
- Diverse experience including drugs and biologics
- Experience with devices
- Familiarity with operational systems (e.g., Trackwise, MasterControl, LIMS, Adobe)
Job Location
This position will be located at our Durham, NC office with a hybrid schedule of 4 days in office and the option to work 1 day each week from home. In office requirements could change based on business needs. This position may travel up to 10%. Relocation assistance may be available for non-local candidates.
Eligible employees may participate in the Company's comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities
