Description
The successful candidate will- Partner with CMC Strategists and communicate regional regulatory requirements and submission strategies for markets in AfME regions.
- Provide CMC post approval variations/renewals, and oversee 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 in the requirements database.
- Responsible for effective project management of CMC submissions for assigned markets.
- Ensure that the CMC change management electronic systems are updated and maintained in alignment with the regulatory information submitted internally by the appropriate functional area.
- Manages timely responses to Board of Health questions resulting from lifecycle submissions in markets under responsibility.
Essential:
- Bachelor's degree or equivalent qualifications in Chemistry, Pharmacy or a related life science field.
- Prior experience in the pharmaceutical or related industry in Regulatory Affairs, Conformance or Compliance.
- Strong knowledge / background of Regional CMC regulatory requirements.
Desirable:
- Experience in authoring CMC submissions
- Has participated in meetings with Regulatory Authorities