The job details are as follows:

What We Do

United Therapeutics Corporation focuses on the strength of a balanced, value-creating biotechnology model. We are confident in our future thanks to our fundamental attributes, namely our commitment to quality and innovation, the power of our brands, our entrepreneurial culture and our bioinformatics leadership. We also believe that our determination to be responsible citizens - having a positive impact on patients, the environment and society - will sustain our success in the long term.

We currently have five approved products on the market and a long-term mission of providing an unlimited supply of transplantable organs for those who need them.

Our company was founded by an entrepreneur whose daughter was diagnosed with a life-threatening condition. She sought to find treatment options and a cure for her daughter and patients like her. We are founder-led, and relentless in our pursuit of "medicines for life". We continue to research and develop treatments for cardiovascular and pulmonary diseases, pediatric cancers and other orphan diseases.

In 2021, we became the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation (PBC). Our public benefit purpose is to provide a brighter future for patients through (a) the development of novel pharmaceutical therapies; and (b) technologies that expand the availability of transplantable organs. At the same time, we seek to provide our shareholders with superior financial performance and our communities with earth-sensitive energy utilization.

How you’ll contribute
Perform CMC and labeling regulatory activities for assigned products, including biologics and drugs. Collaborate with manager and other functional areas to implement sound regulatory CMC and labeling strategies. Provide regulatory guidance on quality related issues and partner with functional areas to update labeling as needed.

• Perform regulatory CMC activities for assigned products and territories
• Update quality sections of regulatory filings (includes INDs, NDAs, BLAs, etc.)
• Review quality submission documents to ensure consistency with related filings and regulatory requirements
• Perform labeling activities for assigned products, as necessary, including editing, review, and QC of content and ensuring consistency with regulatory requirements as well as assisting with internal labeling team meetings
• Interact with UT manufacturing and quality groups, contract and partner organizations as necessary regarding CMC and labeling regulatory issues
• Assist in dossier preparation and provide timely updates for partner organizations in worldwide territories, ensuring accuracy and consistency
• Perform other duties as assigned

United Therapeutics  Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities

For this role you will need

Minimum Requirements

• Bachelor’s Degree in Arts/Sciences (BA/BS) preferably in a science-related field
• 3+ years of experience in the pharmaceutical/biotech or related industry
• 2+ years of experience in a regulatory CMC function or related position
• Excellent organizational, multitasking, and communication skills
• Strong attention to detail
• Strong technical knowledge and proficient in use of MS Office suite

Preferred Qualifications

• Experience with electronic publishing tools (eCTDs), electronic document management systems, or other specialized software used within the pharmaceutical industry
• Diverse experience including biologics and drugs. Experience with devices would be useful
• Experience with drug, biologics, and device labeling
• Familiarity with operational systems (e.g., MasterControl, LIMS, Adobe)

Minimum Requirements for Senior Level:

• Bachelor’s Degree in Arts/Sciences (BA/BS) preferably in a science related field
• 5+ years of direct experience with a regulatory affairs CMC role
• Excellent organizational, multitasking, and communication skills
• Strong attention to detail and project completion
• Experience and comfort working independently and as part of a team on multiple projects with ability to prioritize effectively
• Strong technical knowledge and proficient in use of MS Office suite
• Experience with electronic publishing tools (eCTDs), electronic document management systems, or other specialized software used within the pharmaceutical industry

Preferred Qualifications for Senior Level:

• Diverse experience including drugs and biologics. Experience with devices would be useful
• Experience with drug, biologics, and device labeling
• Familiarity with operational systems (e.g., MasterControl, LIMS, Adobe)

At United Therapeutics, you’ll realize quickly that it is not an ordinary place to work! When you join our company, you will learn, grow, contribute, have fun, and be challenged... all while making a difference in the lives of our patients.

United Therapeutics  Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities