Job Title: EU/RoW Project Manager, Regulatory Affairs/ Snr
Reports to: Director Project Management, Regulatory Affairs
Location: Rapperswil, Switzerland
Position Summary
The Regulatory Project Manager (RPM) is responsible for the end to end management of EU and Rest of World (RoW) regulatory activities. This role works closely with internal and external partners to plan, track, coordinate and report on all regional Health Authority submissions across product lifecycles.
The RPM owns the Smartsheet ecosystem for submission status, country-specific adaptations from the Global Core Dossier, approval timelines, and Request for Information (RFI) tracking, and communicates progress through dashboards and executive-ready slide materials.
Seeking talented individuals with an entrepreneurial drive who will thrive in our collaborative, fast-paced environment and share in our mission to help others.
Responsibilities
Apply project/program management discipline across multiple assets to enable timely, high-quality regulatory submissions and lifecycle activities
Build and maintain integrated regulatory timelines with cross-functional dependencies (CMC, Nonclinical/Clinical, Safety, PV, Labeling, Commercial, Medical).
Maintain a country submission tracker covering target/actual submit dates, validation, clock starts/stops, milestones, and approval dates.
Track submission preparation progress, including but not limited to post-marketing and annual reporting commitments, to ensure timely filing to health authorities.
Maintain a Global Core Dossier adaptation log per country (module/section level) noting local requirements, deviations, justifications, and source/owner.
Coordinate with Regulatory Operations on publishing plans, submission readiness, and version control; ensure alignment with eCTD requirements.
Facilitate Regulatory EU/RoW working sessions: schedule, set agendas with Regulatory Leads, capture/distribute minutes, and drive action item closure.
Prepare executive-ready updates and slide presentations for governance forums and senior leadership
Maintain a structured archive of agendas, minutes, trackers, and key decisions
Drive rapid response tasking and cross-functional alignment to meet health authority response timelines; document outcomes and learnings.
Continuously improve regulatory PM processes and templates; implement SOP/WI compliance in daily operations.
Education/Experience Requirements
Bachelor’sdegree in related Life Sciences discipline. MS, Pharm D, PhD preferred. Equivalent combination of education and applicable job experience may be considered.
Minimum 6 years of Project Management experience in Biotech or Pharmaceutical industry. Regulatory specific project management experience preferred.
PMP certification preferred
Expertise with timeline development and management software required (e.g., MS Project, Smartsheets).
Working knowledge of eCTD structure and publishing workflows; familiarity with RIM systems (e.g., Veeva Vault RIM) is a plus.
For more information, please reach out to lucy.kirkaldy@cpl.com you must be able to attend the office 2/3 days per week.
#J-18808-Ljbffr