Senior Regulatory Affairs Consultant - Regulatory Project Manager

For our client, we are seeking a Senior Regulatory Affairs Consultant - Regulatory Project Manager to join the team of a leader in the Pharmaceuticals & Biotech space.

This role will guide regulatory project execution across global development programs, translating high-level strategy into clear, actionable plans with milestones, risks, and deliverables. You will partner closely with Global Regulatory Leads and cross-functional stakeholders to drive alignment, accountability, and timely decision-making. The work will center on advancing complex submissions and supporting strategic regulatory pathways in a highly visible, fast-moving environment.

Location:

Remote

Compensation: $120,000 – $145,000 annually

• Partner with Global Regulatory Leads to develop and execute regulatory plans
• Translate regulatory strategy into actionable plans with defined milestones and risks
• Lead execution of regulatory plans, ensuring alignment with operational and strategic objectives
• Identify innovative regulatory pathways that align with global expectations
• Drive clarity and accountability for regulatory deliverables across cross-functional teams
• Facilitate global regulatory subteam meetings with a focus on decision-making and risk mitigation
• Prepare strategic dashboards and reports for senior stakeholders, translating regulatory progress into insights

• BA/BS in a scientific, engineering, or healthcare discipline
• Advanced degree such as an MS, PharmD, or PhD and/or PMP preferred
• 7+ years of experience in the pharmaceutical, biotechnology, or related life sciences industry, including at least 5 years in regulatory management
• Proven experience leading regulatory strategy execution across all product development stages, including IND, BLA, and MAA submissions
• Deep understanding of U.S. and EU regulatory requirements; knowledge of global regulations is a plus
• Hands-on experience with eCTD and regulatory documentation, formatting, and submission strategies

• Work-from-home flexibility
• Opportunity to influence global regulatory strategy
• Involvement in groundbreaking vaccine development
• High visibility cross-functional role
• Support for continuous learning and improvement in regulatory practices

Our client is an equal opportunity employer. We encourage you to apply even if you don’t meet every qualification—your background could be exactly what this team needs.