Regulatory Affairs Project Manager - EMEA/APAC
4266154929
Posted: 14/07/2025
- European Union (Remote)
- Contract
Job Title: Regulatory Affairs Project Manager - EMEA/APAC
Contract Duration: 5 Months
Location: Remote
We’re hiring a Regulatory Project Manager to lead the planning and coordination of regulatory submission activities across global teams.
Key Responsibilities:
- Own the development and implementation of granular dossier submission plans
- Collaborate closely with Functional Areas (FAs), especially Medical Writing (MW), to ensure feasibility and explore acceleration opportunities
- Build and manage submission project plans with clear interdependencies and scenario planning
- Co-create and manage the Document Review Matrix with MW to define reviewers and approvers for each document draft
- Coordinate and support Kick-Off Meetings (KOMs), including stakeholder identification, slide creation, and RPM topic presentation
- Maintain and adapt submission timelines, including scheduling key meetings and calendar reminders
- Identify, log, and track submission risks and mitigation strategies
- Lead submission team meetings: plan agendas, record minutes, track actions and decisions
- Ensure effective cross-functional communication with senior leadership and key stakeholders
- Partner with Regulatory Operations (RegOps) to ensure timely delivery of dossier components for publishing
- Forecast and support post-submission activities
- Conduct lessons learned and facilitate archival of all key project documentation
Requirements:
- Strong background in regulatory affairs and/or project management in a life sciences or pharma environment
- Exceptional communication and organizational skills
- Proven experience working with submission teams and regulatory timelines
- Detail-oriented with the ability to manage multiple workstreams under pressure
- Collaborative mindset and leadership in cross-functional environments
If you are interested in finding out more about this role or others, please contact Sharleney Chandraratna at schandraratna@i-pharmconsulting.com or call: +44 (0) 2075510732
Sharleney Chandraratna
Senior MSP Consultant
