Senior Regulatory CMC Consultant

Highly Competitive
  1. Permanent
  2. Consultant / Specialist
  3. United Kingdom
West London, England
Posting date: 14 May 2021
37571

We are looking for Senior Regulatory CMC Consultant to develop key initiatives proposed by the manufacturing part of the business. You will also be expected to provide regulatory advice to colleagues in the manufacturing organisation

Job Responsibilities

  • Development of regulatory strategy for key initiatives proposed by the manufacturing part of the business including sourcing changes on the API and Drug Product (requirements, timelines, specific market issues etc)
  • Provision of regulatory advice to colleagues in the manufacturing organisation
  • Creation and maintenance of regulatory plans
  • Interface with other regulatory departments within Global Regulatory Affairs
  • Responding to agency questions as required
  • Identifying improvement opportunities for CMC Regulatory processes, policies and systems
  • Providing feedback on progress and challenges to key stakeholders
  • Contribute to the maintenance of global CMC regulatory intelligence
  • May contribute to process improvement and/or regulatory intelligence projects

Skills and Requirements

  • Minimum 5 years CMC experience
  • Good written and oral communication and networking skills
  • Be aware of the contents of a marketing authorisation application
  • Demonstrate team working and effective time management skills
  • Ability to efficiently interact with customers and senior stakeholders as required

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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