Regulatory Affairs Manager / Senior Regulatory Affairs Manager - Biologics

United Therapeutics Corporation•RTP, NC, NC

1d•Hybrid

About The Position

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.

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

Nice To Haves

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

Responsibilities

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