Regulatory Affairs Manager / Senior Regulatory Affairs Manager - Biologics
United Therapeutics Corporation
June 26, 2026
Remote friendly (Raleigh-Durham-Chapel Hill Area)
United States
Corporate Functions
Who You Are
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. Partner cross‑functionally to apply regulatory requirements and guidance to development strategies, ensuring high‑quality, timely regulatory submissions and lifecycle management. Serve as primary regulatory point of contact for assigned projects under the direction of regulatory leadership.
Responsibilities:
- Apply principles of applicable regulations and guidance documents from early development through post-approval
- Provide regulatory support for assigned products/projects; coordinate cross-functional activities (nonclinical, clinical, quality, marketing, safety, medical) to meet timelines
- Prepare and maintain regulatory applications and submissions (INDs/INADs/CTAs, NDAs, NADAs, BLAs, MAAs, amendments, supplements, orphan applications, pediatric investigational plans, environmental impact assessments, etc.) in compliance with health authority regulations
- Manage and review submission documents to ensure consistency with related filings and requirements
- Serve as regulatory representative with health authorities, CROs, and partners, as necessary
- Perform product registration and post-approval activities per regulatory strategies
- Support other regulatory/compliance activities as required
Minimum Requirements:
- Regulatory Affairs Manager: BS in science + 8+ years; or MS + 6+ years; or PhD/PharmD/MD + 2+ years
- Senior Regulatory Affairs Manager: BS + 10+ years; or MS + 8+ years; or PhD/PharmD/MD + 5+ years
- Experience with eCTDs/electronic document management or specialized pharmaceutical software
- Knowledge of FDA regulations/guidance, ICH, GCP, and/or GMP
- Problem-solving, organizational, analytical, critical thinking skills
- Proficient in MS Office
Preferred Qualifications:
- Master’s or PhD in a science related field
- RAC (RAPS)
- Experience from pre-IND through Phase 3
- Knowledge of biologics regulations/guidance
- Experience with submissions for monoclonal antibodies, xenotransplantation products, cell therapy, and animal biotechnology
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. Partner cross‑functionally to apply regulatory requirements and guidance to development strategies, ensuring high‑quality, timely regulatory submissions and lifecycle management. Serve as primary regulatory point of contact for assigned projects under the direction of regulatory leadership.
Responsibilities:
- Apply principles of applicable regulations and guidance documents from early development through post-approval
- Provide regulatory support for assigned products/projects; coordinate cross-functional activities (nonclinical, clinical, quality, marketing, safety, medical) to meet timelines
- Prepare and maintain regulatory applications and submissions (INDs/INADs/CTAs, NDAs, NADAs, BLAs, MAAs, amendments, supplements, orphan applications, pediatric investigational plans, environmental impact assessments, etc.) in compliance with health authority regulations
- Manage and review submission documents to ensure consistency with related filings and requirements
- Serve as regulatory representative with health authorities, CROs, and partners, as necessary
- Perform product registration and post-approval activities per regulatory strategies
- Support other regulatory/compliance activities as required
Minimum Requirements:
- Regulatory Affairs Manager: BS in science + 8+ years; or MS + 6+ years; or PhD/PharmD/MD + 2+ years
- Senior Regulatory Affairs Manager: BS + 10+ years; or MS + 8+ years; or PhD/PharmD/MD + 5+ years
- Experience with eCTDs/electronic document management or specialized pharmaceutical software
- Knowledge of FDA regulations/guidance, ICH, GCP, and/or GMP
- Problem-solving, organizational, analytical, critical thinking skills
- Proficient in MS Office
Preferred Qualifications:
- Master’s or PhD in a science related field
- RAC (RAPS)
- Experience from pre-IND through Phase 3
- Knowledge of biologics regulations/guidance
- Experience with submissions for monoclonal antibodies, xenotransplantation products, cell therapy, and animal biotechnology