Regulatory Affairs Manager - CMC & Labeling

United Therapeutics Corporation; United States; Hybrid; USD 120,000 - 190,000; Full time

Job summary

United Therapeutics Corporation in Durham, NC is seeking a Regulatory Affairs Manager (CMC) to lead submission planning for US, EU, and ROW. Hybrid work with 4 days in office and up to 1 day remote weekly, travel up to 10%, and relocation assistance for non-local candidates.

The role requires extensive CMC knowledge, collaboration with manufacturing and QA, and leadership of junior staff to ensure timely, compliant regulatory deliverables across multiple projects in a fast-paced biotech

Qualifications

• Bachelor’s degree in science required; advanced degrees preferred.
• 8+ years in regulatory affairs CMC with Bachelor’s, or 6+ with Master’s, or 2+ with PhD/PharmD.
• Experience with electronic publishing tools (eCTD) or related software.
• Strong organizational, multitasking and communication skills; attention to detail.

Responsibilities

• Manage and lead regulatory CMC activities to meet timelines and department goals for assigned products and territories, delegating tasks as required.
• Manage and lead updates to quality sections of regulatory filings (INDs, NDAs, BLAs, etc.) and review of quality submission documents for consistency with filings and regulatory requirements.
• Interact with manufacturing and quality groups, contract and partner organizations regarding CMC regulatory issues and provide strategic CMC regulatory interpretation and guidance to project teams.
• Mentor junior regulatory personnel; direct and manage training, goal setting, performance evaluations, and recruitment support as needed.
• Perform and lead labeling activities, including editing, review and QC, ensuring regulatory compliance and leading internal labeling team meetings.
• Work independently on assigned projects using knowledge, experience, data interpretation, analyses, and problem-solving to resolve complex CMC issues.
• Assist in dossier preparation and provide timely updates for partner organizations in worldwide territories.
• Contribute to other regulatory and compliance activities with project teams and other regulatory personnel.
• Implement new technologies, practices, methods, or regulatory agency guidance applicable to job function.
• Perform other duties as assigned.

Skills

Organizational skills

Multitasking

Communication skills

Team leadership

MS Office

Regulatory affairs knowledge

Education

Bachelor’s degree in science

Master’s degree in science (preferred)

PhD or PharmD (preferred)

Tools

eCTD publishing tools

TrackWise

MasterControl

LIMS

Adobe

Job description

California, US residents click here.

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 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.

At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good.

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

United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.