Senior Regulatory Associate - CMC

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.

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