Sr. Regulatory Affairs Professional, Global TA

Role: Sr. Regulatory Affairs Professional, Global TA supporting innovative medicine programs across diverse therapeutic areas and development stages. Responsibilities: participate in global/regional regulatory teams, advise on requirements, prepare agency interactions, ensure timely responses to agency queries, review clinical and submission documents, develop regulatory strategies, and support inspections/audits. Collaborate cross-functionally, stay informed on regulatory guidelines, and serve as secondary contact with Health Authorities. Requirements: Bachelor’s in a scientific discipline plus 6 years’ experience in academia or industry; or PharmD/PhD with 2+ years, or Master’s with 3+ years. Experience with drug development, regulatory submissions, and agency interactions preferred. Skills include regulatory strategy, compliance, project management, communication, and problem-solving. HighValue: experience in regulated pharma/biotech environment, understanding US/EMA guidelines, life-cycle management, and cross-functional teamwork. Location: Spring House, PA, Raritan, NJ, or Titusville, NJ; likely hybrid. The role offers broad exposure to regulatory processes for early to late-stage drug development, supporting marketed products and pipeline compounds in a fast-paced, innovative setting.