Description
If successful, you will- Partner with CMC Strategists and communicate regional regulatory requirements and submission strategies for Emerging Markets Europe regions
- Provide quality CMC post approval variations/renewals, and overseeing delivery of initial submissions in the region by developing submission strategy, partnering with the product lead to receive CMC dossier content and collating components required to meet market needs
- Ensure thorough and accurate regional knowledge of CMC regulatory requirements, and that this is recorded/maintained in the requirements database
- Be responsible for effective project management of CMC submissions for assigned markets using the Submission Planning Application
- Ensure that the CMC change management electronic systems are updated and maintained in alignment with the regulatory information submitted externally or internally
- Manage timely responses to Board of Health questions resulting from lifecycle submissions
- Comply with relevant Department and Company Standard Operating Procedures (SOP's)
Desireable qualifications:
- Bachelor's degree or equivalent qualifications in Chemistry, Pharmacy or a related life science field
- Prior experience in the pharmaceutical industry in Regulatory Affairs
- Strong knowledge of Regional CMC regulatory requirements
- Experience in authoring CMC submissions
- Previous participatation in meetings with Regulatory Authorities