Our client a Global Pharmaceutical organisation have opened a new vacancy within their Regulatory Affairs team and are actively seeking to recruit a Senior Regulatory Officer CMC to work at their offices in Kent on an initial 6 Month contract basis. This role will be remote working to begin with due to COVID-19.
- Prepare high quality Regulatory CMC documentation, with a focus on post approval submissions for the respiratory product portfolio across global territories
- Conducting GAP analysis and remediation activities for regulatory documentation
- Responsible for managing multiple concurrent submissions, ensuring tracking of deliverables.
- Processing change controls for the respiratory portfolio
- Ensuring high level of quality through review and checking of Regulatory submissions
- Preparing, assisting and supporting CMC Regulatory related work as directed by supervisor
- Pharmacy, Chemistry or Life Sciences Degree
- Experience with the preparation Regulatory CMC documents
- Experience working in Regulatory CMC or related department within pharmaceutical sciences
- Be able to work as self-starter with minimal supervision
- Experience working in a Document Management System
- Proficient in use of Microsoft Word and Excel
- Proficiency in speaking, comprehending, reading and writing English is required
If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: Natasha.Rollason@srgtalent.com or +441753 589673
your application has been submitted