Regulatory Consultant - CTA

Highly Competitive
  1. Permanent
  2. Consultant / Specialist
  3. United Kingdom
London, England
Posting date: 02 Jun 2021
37947

A fantastic vacancy has become available for a Senior Regulatory Consultant working remotely from home. You will need to be able to support Clinical trials, providing regulatory expertise.

Job Responsibilities

  • Provide regulatory input to commercial strategic and operating planning process.
  • Attend relevant product team meetings with cross-divisional colleagues to provide technical guidance and support for teams as necessary.
  • Work with above country regulatory strategists (AC-RS) to provide country input into Global and European Regulatory Strategies as required.
  • Seek to improve alignment of local and regional regulatory strategy and tactics.
  • Use expert knowledge of EU/national legislation, guidelines, regulatory environment to provide insightful responses to enquiries from cross-divisional colleagues and direct or indirect interactions with external customers.
  • Manage and Submit Marketing Authorisation Applications: National/MRP/Decentralised MAA:
  • Manage and Submit MA Variation Applications
  • Prepare agreed Module 1 documents in partnership with above-country operational hubs. Lead MRP/DCP submission review and planning where country is RMS, in conjunction with AC-RS
  • Proactively take opportunities to develop or enhance working relationships with Regulatory Authorities and trade associations.
  • Manage Clinical Trial Approvals (if performed in country

Skills and Requirements

  • Life sciences or chemistry graduate to honours level or equivalent
  • Master's Degree, Post Graduate Diploma or PhD preferred
  • Previous experience and proven track record in Regulatory Affairs

To Apply

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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