Regulatory Project Manager (Global Submissions)

About the role

The Regulatory Project Manager will independently manage regulatory submissions and support internal RPM in major global filings. Working closely with cross‑functional teams, you will coordinate timelines, lead submission working groups and ensure compliance across multiple markets.

Key responsibilities

• Independently manage regulatory submissions and support initial major global filings.
• Co‑lead submission working groups (SWGs) with designated regulatory leads for non‑major markets.
• Develop and maintain project timelines, identify critical paths and resource constraints.
• Schedule and facilitate kick‑off meetings, prepare agendas, collect presentations and record minutes.
• Maintain decision and risk logs, update submission plans and RPP as needed.
• Create and manage SWG sites, dashboards and scenario‑planning documents.
• Attend functional sub‑team meetings for modules 2‑5 to track high‑level submission milestones.

Required profile

• 5–10 years of experience in regulatory project management within life‑sciences, pharmaceutical or medical‑device sectors.
• Proven ability to manage end‑to‑end regulatory submissions and lead cross‑functional teams.
• Strong organizational skills with experience in timeline creation, risk management and stakeholder coordination.

Required skills