Remote Global Regulatory Project Manager - Vaccines
Parexel
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Job summary
Parexel is seeking a seasoned Regulatory Project Manager to shape global regulatory strategy and drive execution from a home-based setting. You will partner with Global Regulatory Leads to align plans across US and international markets, guiding complex development and registration programs, and ensuring cross‑functional teams stay focused on milestones and decisions.
The role emphasizes risk anticipation, leadership, and timely regulatory decisions to support transformative vaccines and
Qualifications
- BA/BS in science or healthcare field required.
- 7+ years in pharma/life sciences with 5+ years in regulatory/program management.
- Experience with IND/BLA/MAA submissions and global registration.
- Knowledge of US/EU regulatory expectations and submission strategies.
Responsibilities
- Shape and execute globally aligned regulatory plans across development stages.
- Translate strategy into actionable regulatory plans with milestones and risks.
- Lead execution of regulatory plans, aligning ops with objectives.
- Propose regulatory pathways and planning scenarios for global goals.
- Collaborate with cross‑functional teams and senior leadership for deliverables.
- Facilitate GRST meetings with structured agendas and decisions.
- Maintain governance, cadence, and communication across teams.
- Anticipate challenges and implement scalable regulatory solutions.
- Deliver dashboards and scenarios to senior stakeholders.
Skills
Education
Tools
Job description
Parexel is seeking a seasoned Regulatory Project Manager to shape global regulatory strategy and drive execution from a home-based setting. You will partner with Global Regulatory Leads to align plans across US and international markets, guiding complex development and registration programs, and ensuring cross‑functional teams stay focused on milestones and decisions.
The role emphasizes risk anticipation, leadership, and timely regulatory decisions to support transformative vaccines and
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