Regulatory Affairs Manager / Senior Regulatory Affairs Manager - Biologics

Regulatory Affairs Manager, Biologics/Senior Regulatory Affairs Manager, Biologics

United Therapeutics 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.

The Regulatory Affairs Manager, Biologics/Senior Regulatory Affairs Manager, Biologics will lead regulatory activities for assigned existing and new programs, supporting product development from early development through post-approval. This role will partner cross-functionally to apply regulatory requirements and guidance to development strategies, ensuring high-quality, timely regulatory submissions and lifecycle management. This role will serve as the primary regulatory point of contact for assigned projects, providing practical regulatory guidance to project teams and supporting interactions with health authorities under the direction of regulatory leadership.

Apply principles of applicable regulations and guidance documents to project teams from early development through post-approval. Provide regulatory support for assigned products/projects, coordinating cross-functional activities with various UTC product development groups (e.g., nonclinical, clinical, quality, marketing, safety, medical) to support execution of regulatory activities and adherence to established timelines. Prepare and maintain new and existing regulatory applications, including investigational and marketing applications (INDs/INADs/CTAs, NDAs, NADAs, BLAs, MAAs, etc.), amendments, supplements, orphan applications, pediatric investigational plans, environmental impact assessments, and other submissions in compliance with health authority regulations. Manage and review submission documents for assigned products/projects to ensure consistency with related filings and regulatory requirements. Serve as a regulatory representative for assigned products/projects, engaging with various regulatory agencies, CROs, and partner organizations, as necessary, under the direction of regulatory leadership, to execute regulatory responsibilities. Perform product registration and post-approval activities as assigned, in accordance with defined regulatory strategies. Support other regulatory and compliance activities as required, partnering with project teams and other regulatory staff. Perform all other duties as assigned.

Minimum requirements for Regulatory Affairs Manager level: Bachelor's degree in a science related field and 8+ years of relevant regulatory affairs experience and/or related industry experience, or Master's Degree and 6+ years of relevant regulatory affairs experience and/or related industry experience, or PhD/PharmD/MD and 2+ years of relevant regulatory affairs experience and/or related industry experience. For Senior Regulatory Affairs Manager level: Bachelor's degree in a science related field and 10+ years of relevant regulatory affairs experience and/or related industry experience, or Master's Degree and 8+ years of relevant regulatory affairs experience and/or related industry experience, or PhD/PharmD/MD and 5+ years of relevant regulatory affairs experience and/or related industry experience. Experience with electronic publishing tools (eCTDs), electronic document management systems, or other specialized software used within the pharmaceutical industry. Knowledge of FDA regulations/guidance, ICH, GCP, and/or GMP standards. Excellent problem-solving, organizational, analytical, and critical thinking skills. Strong technical knowledge and proficient in use of MS Office.

Preferred qualifications: Master's degree in a science related field. Doctor of Philosophy (PhD) in a science related field. Regulatory Affairs Certifications (RAC)-RAPS. Experience with clinical research and product development from pre-IND through Phase 3. Knowledge of biologics regulations/guidance. Experience with the preparation of regulatory submissions related to monoclonal antibodies, xenotransplantation products, cell therapy, and animal biotechnology.

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 15%. Relocation assistance may be available for non-local candidates.