Regulatory Affairs Project Coordinator - 290

In the context of our growing activities, we are looking for a Regulatory Affairs Project Coordinator to join our teams from France.

You will integrate a team of Regulatory Affairs professionals dedicated to one of our main French clients and will have to coordinate activities for this client as well as taking responsibility for post-MA regulatory activities related to International and EU markets for this client.

• Provide guidance and support to the client on regulatory strategies and any other requests on International and European markets
• Act as a key contact point for the client regarding the organization of the workload in the different subteams
• Act as a key contact for Project Management for quality of work and KPI follow up and invoicing validation
• Act as a key contact of our PLG referents within the 4 subteams working on:
  –RA International activities: renewals, safety and quality variations for 3 therapeutics areas in French speaking area and non French speaking area
  –RA European activities: renewals, safety and quality variations for 3 therapeutics areas
  -Management of CCDS (Company Core Data Sheet) and Product Information updates
  -Management of CEP (Certificate of Suitability) and ASMF (Active Substance Master File): regulatory assessment of new versions and writing of variation packages
• Responding to internal requests for technical and/or regulatory information
• Ensuring compliance with all regulatory processes, in readiness for both internal and external audits
• Monitor and maintain up-to-date knowledge of international and European guidelines/legislation
• Use a variety of software packages to produce correspondence and documents, maintain spreadsheets and databases, and locate information and data eg Microsoft Office Suite, Veeva Vault (or comparable EDMS), LorenZ, Trackwise, PromoMat etc
• General regulatory administration duties and compliance requirements
• Document and track regulatory submissions and regulatory authority approval.
• Contribute to data entry in PLG tools enabling measurements of KPI, metrics for regulatory services

• At least a Bachelor’s Degree in Life Sciences, ideally a Pharmacy Degree (PharmD)

• At least 3 years of experience in Regulatory Affairs in a Pharmaceutical Company or Service Provider
• International markets LifeCycle Maintenance (LCM) experience
• EU LifeCycle Maintenance (LCM) experience
• Experience in managing CCDS (Company Core Data Sheet) and Product Information updates
• Experience in managing CEP (Certificate of Suitability) and ASMF (Active Substance Master File)
• Ideally Line Management experience to manage 5 people based in India and Tunisia

Hard/Technical skills:

• Great managerial skills
• Excellent project management and coordination skills
• Strong computer skills, including MS Office applications, data and document management systems
• Experience of promotional/non-promotional activities would be an advantage
• Fluency in French and English is mandatory

Soft skills:

• Excellent communication skills
• Excellent organizational and interpersonal skills
• Very good coordination skills
• A proven ability to consistently deliver to tight timelines, without negatively impacting on quality or departmental budget
• Ability to work well within a team and autonomously
• Ability to prioritize different workloads/multi-task
• Process orientated with good attention to detail
• Solution-driven