FSP - Sr Regulatory Program Manager

About the role

For our client, we are seeking a FSP - Sr Regulatory Program Manager to join the team of a leader in the Pharmaceuticals & Biotech space. This role will guide global regulatory planning and execution across the product lifecycle, with a strong emphasis on development and post-marketing strategy. You will work closely with global regulatory leaders and cross-functional partners to translate strategy into actionable plans, manage milestones, and drive regulatory readiness in a fast-paced, highly visible environment. The position requires strong program leadership, sound judgment, and the ability to influence senior stakeholders while navigating complex regulatory expectations in a matrixed organization.

Location: Remote - US based candidates only, no visa sponsorship available

Responsibilities

• Partner with global regulatory leads to shape and execute comprehensive global regulatory plans throughout product development and post-marketing
• Translate regulatory strategies into actionable plans with clear milestones and risk assessments
• Lead execution of regulatory plans, aligning daily operations with strategic objectives
• Propose innovative regulatory pathways that align with global expectations and business goals
• Collaborate with cross-functional teams to ensure clarity and accountability for regulatory outcomes
• Facilitate GRST meetings with focus on structured decision-making, risk mitigation, and execution effectiveness
• Anticipate and address complex regulatory challenges, implementing solutions to enhance team effectiveness

Qualifications

• BA/BS in a scientific, engineering, or healthcare field; advanced degree (MS, PharmD, PhD) or PMP certification preferred
• 7+ years of experience in pharmaceutical, biotechnology, or related life sciences industry, with 5+ years in regulatory or program management
• Proven ability to lead regulatory strategy from development to post-marketing, including IND/BLA/MAA submissions
• Deep knowledge of U.S. regulations and international agency expectations
• Experience managing complex regulatory deliverables in a matrixed organization
• Hands-on experience with eCTD and regulatory documentation
• Exceptional communication and influencing skills, with the ability to translate complex information for senior stakeholders

Benefits

• Work in a highly visible, cross-functional role that enhances personal visibility within the organization
• Opportunity to partner with leading global regulatory teams on innovative mRNA medicines
• Engagement in a fast-paced, innovative environment that fosters professional growth and learning