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.
- 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.
A full job description is available on request.