Role OverviewThis role is designed for an experienced and forward-thinking regulatory project manager who thrives in a fast-paced, innovative environment and can seamlessly integrate strategic thinking with operational execution across all stages of product development, registration, and post-marketing. As a key member of the Global Regulatory Science team, you will partner strategically with Global Regulatory Leads to shape and execute comprehensive regulatory strategies for the U.S. and ex-U.S. markets. This is a highly visible, cross-functional role requiring strong leadership, agility, and strategic foresight.
What You Will Do
Partner strategically with Global Regulatory Leads to shape and execute forward-looking, globally aligned regulatory plans across all stages of development and post-marketing. Translate regulatory strategy into integrated, actionable plans with clear milestones, critical paths, risks, and opportunities. Lead the execution of regulatory plans, ensuring alignment between day-to-day operations and broader strategic objectives across global programs. Facilitate Global Regulatory Subteam (GRST) meetings and other routine and ad hoc project review forums, ensuring meetings are purpose-driven, well-structured, and focused on decision-making, risk mitigation, and regulatory execution.
Why It Might Be a Fit
You bring a BA/BS degree in a scientific, engineering, or healthcare discipline, with an advanced degree (MS, PharmD, PhD) and/or PMP certification strongly preferred. You have a minimum of 7 years of progressive experience in the pharmaceutical, biotechnology, or related life sciences industry, with at least 5 years in regulatory or regulatory program management. You have proven ability to partner on regulatory strategy and lead execution across all stages of product development, including IND/BLA/MAA submissions, global registration, and post-marketing activities. You have deep understanding of U.S. regulatory requirements with working knowledge of international (ex-U.S.) regulations and agency expectations.
Requirements
- BA/BS degree in a scientific, engineering, or healthcare discipline required; advanced degree (MS, PharmD, PhD) and/or PMP certification strongly preferred
- Minimum of 7 years of progressive experience in the pharmaceutical, biotechnology, or related life sciences industry, with at least 5 years in regulatory or regulatory program management
- Proven ability to partner on regulatory strategy and lead execution across all stages of product development, including IND/BLA/MAA submissions, global registration, and post-marketing activities
- Deep understanding of U.S. regulatory requirements with working knowledge of international (ex-U.S.) regulations and agency expectations
- Demonstrated success managing complex regulatory deliverables across cross-functional teams within a matrixed organization, while maintaining alignment to strategic priorities
- Hands-on experience with eCTD and a strong command of regulatory documentation, formatting, and submission strategy
- Exceptional communication and influencing skills, with the ability to synthesize complex regulatory information and translate it into clear recommendations for senior leadership and global stakeholders
- Strong judgment and agility in managing competing priorities, resource constraints, and evolving program needs with flexibility and strategic foresight
- Demonstrated ability to leverage project management tools and best practices to enhance visibility, efficiency, cross-functional alignment, and meeting effectiveness across GRSTs and project teams
- Demonstrated experience facilitating cross-functional team meetings, driving structured agendas, documenting decisions and actions, and maintaining strong meeting hygiene and team accountability in a matrixed environment
- Expert skills required for Smartsheet and Microsoft Office Suite
- Expert in creating visuals using PPT generated from timeline integration tools (ie, One Pager, Office Timeline Pro, etc.)
- Proficient user of Veeva Regulatory Information Management (RIM)
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