Regulatory Affairs Manager - Consumer

Highly Competitive
  1. Permanent
  2. Project Manager
  3. United Kingdom
Wokingham, England
Posting date: 20 Aug 2020
31369

Here is a chance to join one of the most globally known pharmaceutical organisations, who is looking to hire a Regulatory Affairs Manager based in Wokingham. This job will be working a top 10 pharmaceutical company that works across a range of industries from medical devices to pharmaceutical and consumer goods, operating in over 60 countries.

Job Responsibilities

  • Supports the team with regulatory activities for National and/or European procedures (Decentralised, Mutual Recognition) as appropriate.
  • Supports the team with regulatory strategies (local and regional) in line with business plan.
  • Supports the team to complete identified regulatory activities to ensure all regulatory obligations and business objectives are met.
  • Prepares and compiles regulatory submissions responses to Regulatory Agency (RA) questions and other correspondence in accordance with EU regulations and guidelines.
  • Ensure Marketing Authorisations are maintained and renewed.
  • Inform the Regulatory Agency/Department of Health (as appropriate) of product discontinuations and licence cancellations.
  • Supports the Northern Cluster team with Calls for Information and assist in any Pharmacovigilance related activities within the Northern Cluster
  • Receive and monitor responses to Calls for Information (CFI) through liaison with UK and EAME colleagues.
  • Ensure responses are submitted in a timely way in line with standard procedures and

Skills and Requirements

  • Regulatory knowledge in regional legislation Working with policies, procedures and SOPs
  • Ideally experience with coordinating and tracking global Regulatory Affairs CMC projects, plus regulatory aspects of national requirements, change control management, and working with cross-functional internal and external stakeholders
  • Experience in Regulatory project management and regulatory writing.
  • Good communication skills and experience working cross-functionally and globally.

To Apply

In case you have difficulty in applying or if you have any questions, please contact Peter Duvall on 44 203 0789 542 or upload your CV on our website - www.proclinical.com/send-cv

A full job description is available on request.

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