Job Details

The Opportunity:  Manager, Regulatory Project Management

Seeking a Manager, Regulatory Project Management to support execution of regulatory planning and major submission activities across our development portfolio. This role will serve as a key operational partner and back-up to the Regulatory Planning lead, helping ensure continuity, cross-functional alignment, and disciplined delivery of regulatory milestones. The Manager will play an integral role in supporting complex submissions by translating regulatory strategy into structured, actionable project plans and driving accountability across cross functional contributors. Working closely with Regulatory Science, Regulatory Operations, and cross-functional stakeholders, this individual will enhance visibility into timelines, proactively identify risks, and help enable efficient, high-quality regulatory execution in a dynamic environment.

• Serve as back-up to the Regulatory Planning lead, ensuring continuity of regulatory planning activities and timeline oversight.

• Support development and maintenance of integrated global regulatory timelines across programs.

• Provide project management support for major submissions, including complex regulatory submission planning and milestone coordination.

• Facilitate Global Regulatory Strategy Team meetings, including agenda coordination, minute-taking, action item tracking, and follow-up with functional team members.

• Develop and maintain detailed submission delivery plans and milestone trackers.

• Monitor progress against commitments and proactively surface risks, dependencies, and resource considerations.

• Prepare clear status updates, dashboards, and planning materials for internal stakeholders.

• Coordinate with Regulatory Operations to align planning outputs with document readiness and submission execution.

• Assist with health authority meeting logistics and cross-functional preparation activities.

• Contribute to enhancement of regulatory planning tools, templates, and processes.

Required Skills, Experience and Education:

• Bachelor’s degree in life sciences or related discipline.

• 5+ years of experience in regulatory affairs, regulatory operations, or regulatory project management within biotech or pharmaceutical industry.

• Experience supporting a major regulatory submission (e.g., NDA, BLA, MAA).

• Working knowledge of global regulatory submission processes and lifecycle management.

• Demonstrated ability to build and manage detailed project timelines in a cross-functional matrix environment.

• Strong meeting facilitation and follow-up skills, with proven ability to drive accountability.

• Proficiency with project planning tools (e.g., Smartsheet, MS Project, or similar platforms).

• Excellent organizational skills and attention to detail.

• Strong written and verbal communication skills.

Preferred Skills:

• Experience supporting NDA submissions in oncology or complex development programs.

• Familiarity with eCTD structure and regulatory publishing workflows.

• Experience with Regulatory Information Management (RIM) systems.

• Proficiency in timeline visualization tools (e.g., OnePager, TimelinePro).

• PMP certification or formal project management training.

• Demonstrated ability to influence cross-functional teams without direct authority.