Regulatory Affairs Platform Manager Europe

Regulatory Affairs Platform Manager Europe

ProductLife Group

Vaulx en Velin, France

As a result of the deployment of a new project we are now seeking a REGULATORY AFFAIRS PLATFORM MANAGER EUROPE for ensuring delivery of regulatory services:

Lead the regulatory platform/hub team and the labelling team.

To ensure the regulatory activities of the regulatory platform/hub are implemented. Regulatory activities include pre-registration activities, new registrations (sites and medications), post-registration regulatory submissions, interaction with health authorities on behalf of PLG customers.

To contribute to the recruitment of platform/hub staff.

Primary Responsibilities

Within our site located in Vaulx en Velin, the missions are:

  • Being the main contact for regulatory matters (supported by colleagues, if applicable). This includes effective coordination with clients, project/mission managers and internal staff.
  • Provide regulatory advice to project teams to ensure that regulatory objectives are considered in the planning and production of relevant data in order to achieve the project objectives.
  • Provide regulatory support to customers and associated businesses Contribute to the selection and qualification of regulatory partners to ensure a comprehensive regulatory service for the regions/countries under its responsibility. Be responsible for monitoring the quality of the services provided by these regulatory partners.
  • Review the tasks, provide support and assist in charge of Regulatory Affairs and Regulatory affairs partners.
  • Before sales:
    • Provide technical support before sales.
    • Carry out an adequate technical description of the proposals and provide support for sales in the cost assessment.
    • Check the proposals.
  • Ensures that invoicing is correctly set. Validate invoices.
  • Contribute to data entry in PLG tools enabling KPI/metric measurements for the regulatory services provided by the platform/Hub.
  • To ensure, with IT, that all the tools necessary for the realisation of the services or the management of the projects are in place and used by the staff of the platform/Hub to ensure that all the technical aspects and the training materials are organised and Shared among the staff of the platform/Hub.
  • Control the data entered into the PLG tools by the platform/HUB staff. Ensure that metric KPIs are adequately measured for all regulatory services provided by the platform/Hub and that they meet or exceed the defined objectives.
  • Be responsible for the control and management of financial systems that provide accurate financial information to the Director General and to the Contracts & Finance director.

Candidate Profile

  • Education: Life Sciences related fields (Pharmacist or Master minimum).
  • Experience: 5 years minimum of professional experience required in a similar position in regulatory affairs and project management.

Key Skills

  • Expert in regulatory affairs registration EU.
  • Excellent organisational and interpersonal skills.
  • Ability to coordinate, lead and motivate a team.
  • You are fluent in French (spoken and written) and English for daily contacts with local and world-wide partners.

Core Competences

  • Project management skills.
  • Rigorous and Pragmatic.
  • Customer- and Quality focus.
  • Result driven , accurate.
  • Problem solving capabilities.

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© EuroJobsites 2019

EuroJobsites is a UK registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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