Regulatory Affairs Manager - CMC & Labeling

United Therapeutics•Rtp, NC

1d•Hybrid

About The Position

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.

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

Nice To Haves

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)

Responsibilities

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