Regulatory Affairs Manager - CMC & Labeling

## Regulatory Affairs Manager - CMC & Labeling Apply remote type:
Hybrid locations:
RTP, NCtime type:
Full time posted on:
Posted Yesterday job requisition :
R05189

California, US residents .
** The job details are as follows:
** Who We Are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs.

United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter’s pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF).The

cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option.

Who You Are Do you have extensive, highly technical CMC knowledge? If you're passionate about getting novel treatments into the hands of those who need them – and you know your way around Module 3 like the back of your hand – you might be exactly who we’re looking for.

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…