Senior Manager, Risk Evaluation and Mitigation Strategies (REMS) Strategy and Submissions

Role: Senior Manager of REMS Strategy and Submissions, overseeing the strategic planning and operational management of REMS programs, including FDA submissions in the US. Responsibilities: support REMS submission processes, develop strategic and detailed project plans, coordinate with internal teams and external vendors, manage stakeholder relationships, contribute to FDA responses, and ensure submission readiness and compliance. Requirements: BS/BA, 5-7 years pharmaceutical industry experience with a focus on Risk Management, Medical Communications, or Regulatory Affairs; prior REMS experience preferred; strong communication, organizational, and Microsoft Office skills; US regulatory knowledge. Preferred: advanced healthcare degree. HighValue: REMS program management, FDA submission coordination, risk management in pharma, cross-functional stakeholder engagement, experience with US regulatory environment. WorkSetup: hybrid in Princeton, NJ.