Regulatory Project Manager (Remote)

About the role

The Regulatory Project Manager (RPM) Support will assist in managing global regulatory projects, supporting submission activities, and coordinating cross‑functional teams to meet regulatory milestones.

Key responsibilities

• Support Submission Working Groups (SWG) by organizing kick‑off and recurring meetings, maintaining detailed submission timelines, RAID logs, and rapid response activities.
• Document lessons learned and provide additional RPM support as required.
• Coordinate and support Global Regulatory Teams (GRT), assist with regulatory project plans, track goals and deliverables, and maintain RAID logs.
• Independently manage non‑SWG submission types and provide extra regulatory project assistance.

Required profile

• Bachelor’s degree in Pharmaceutical Sciences, Medical Sciences or related field, or equivalent experience.
• 4–6 years experience in the pharmaceutical or life‑sciences industry, with at least 2 years in project management, preferably regulatory affairs or operations.
• Experience supporting regulatory submissions for major markets (US, EU, etc.).

Required skills

• Experience with IND, NDA, BLA, EU MAA and EU variation submissions.
• Familiarity with regulatory project planning and submission tracking.
• Proficiency in Microsoft Project or equivalent tools.
• Advanced use of Microsoft Office (Word, Excel, Outlook).

What we offer

• Competitive salary and benefits package.