FSP - Sr Regulatory Program Manager - client dedicated
About the role
For our client, we are seeking a Sr Regulatory Program Manager to join the team of a leader in the Pharmaceuticals & Biotech space. This role will drive regulatory program execution for client-dedicated work, helping translate global regulatory strategy into clear plans, milestones, and risk management actions. You will partner closely with regulatory leadership and cross-functional teams to coordinate deliverables, improve subteam meeting effectiveness, and keep complex submissions on track across international markets. The position requires strong program leadership, regulatory fluency, and the ability to bring structure and accountability to a matrixed environment.
Responsibilities
- Partner with global regulatory leads to develop and execute regulatory plans
- Translate regulatory strategies into actionable plans with clear milestones and risks
- Lead execution of regulatory plans, aligning operations with strategic objectives
- Identify innovative regulatory pathways that meet global expectations
- Collaborate with cross-functional teams to ensure accountability for regulatory deliverables
- Facilitate effective global regulatory subteam meetings with structured agendas and a decision-making focus
- Apply project management best practices to enhance meeting effectiveness and documentation
Qualifications
- BA/BS in a scientific, engineering, or healthcare discipline; advanced degree (MS, PharmD, PhD) and/or PMP certification preferred
- 7+ years in pharmaceutical, biotechnology, or life sciences, with 5+ years in regulatory or program management
- Experience with IND/BLA/MAA submissions and global registration processes
- Strong understanding of U.S. regulatory requirements and international regulations
- Proven ability to manage complex regulatory deliverables in a matrixed organization
- Hands-on experience with eCTD and regulatory documentation
- Exceptional communication skills for synthesizing complex information
Compensation
$120,000 – $145,000 annually
Location & Schedule
Remote — US-based candidates only; no visa sponsorship available. Standard Monday to Friday work schedule.
Benefits
- Office-based work environment