Chargé d’affaires réglementaires Job in Paris (75) at KGR –

Détails du poste

Temps plein | CDIil y a 1 jour

Description complète du poste

We are recruiting a Regulatory Affairs Specialistfor a global not-for-profit organization in Paris.

Your tasks :

  • Coordinate with the team to plan, organize and submit regulatory submissions to national Health Authorities
  • Address regulatory queries from notifying bodies, Health Authorities and distributors and maintain regulatory approvals
  • Ensure that all regulatory dossiers are maintained and updated to the highest professional standards
  • Ensure proper document retention / archiving of all Regulatory documents.
  • Update Global Database and RAMS directory
  • Support and at time lead the annual Regulatory Intelligence Exercise
  • Liaise with Regulatory Affairs and Commercial to plan registration, renewal and variation activities around the strategies that have been chosen
  • Responsible for the regulatory landscape assessment and meet with local stakeholders
  • Prepare and follow up product dossiers as per country guidelines as necessary to obtain and sustain product approval
  • Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents, and maintain regulatory intelligence database
  • Review and make recommendations and liaise with QA team on all relevant documentation
  • Effectively communicate the status of submissions with the team
  • To ensure that all product labelling complies with the Regulatory Authorities’ requirements and internal SOPs where products are marketed
  • Foster professional working relationships with internal and external contacts
  • Act as EU RP for MVA – Within the scope of medical regulation

Your profile :

  • Strong interpersonal skills
  • Proficiency in all MS-Office
  • Excellent knowledge of EU regulatory medical device guidelines
  • Bachelor’s Degree in Chemistry or Life Sciences or similar
  • Previous experience within the pharmaceutical/medical device industry within Regulatory Affairs
  • English, French Fluent, additional languages skills such as Spanish ,Arabic or Portuguese

Job Types: Full-time, Permanent

Work Location: One location

About the Company

Company: KGR –

Company Location:  Paris (75)

Estimated Salary:

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About KGR -