Senior Regulatory Associate - CMC

Highly Competitive
  1. Permanent
  2. CMC
  3. United Kingdom
Uxbridge, England
Posting date: 18 Sep 2020

An exciting opportunity has arisen for a Senior Associate Regulatory Affairs (CMC) provides varying levels of product support to the Chemistry, Manufacturing and Controls.

Job Responsibilities

  • Co-ordinate the preparation of high-quality CMC documents to support regulatory submissions in International regions
  • Work with pharmaceutical development, manufacturing, QA and external partners to deliver the CMC components for marketing applications, variations and renewals
  • Co-ordinate the preparation of responses to CMC questions from regulatory authorities
  • Maintain an up to date awareness of CMC regulatory requirements for applicable territories and communicate key intelligence to the organization in a timely manner

Skills and Experience

  • Minimum BA in Life Science related degree
  • 2 years of Regulatory, Compliance or related Science experience
  • Proficient skills in Microsoft Office suite, especially Word, Excel, PowerPoint and Project
  • Adept interpersonal and communication skills (both verbal and written)
  • Ability to work both independently and as a member of a team.

To Apply

A full job description is available on request.