Regulatory Affairs Specialist

il y a 1 mois


Paris, France KGR Temps plein

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
- Support QA team
- Act as EU RP for MVA - Within the scope of medical regulation

Your profile:

- Management skills
- 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



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