Description
Objective:- To assist the Regulatory Affairs manager to implement the Regulatory Affairs strategy
- Support the integration of a new product portfolio
- To generate high quality regulatory submissions to target markets in order to deliver a successful and timely portfolio of MA approvals in accordance with the company's requirements
- Following MA approvals, maintenance of the MA approval activities including preparation and submission of variations and preparation for product launch
- Successfully interact with the project and functional teams to ensure that data generated is appropriate and will be presented and compiled in accordance with requirements
Key Responsibilities & Requirements:
- Must have Documentum and/or docuBridge experience
- Complete dossier submissions for projects in a timely manner
- Experience of the submission process (DCP, MRP, CP or national submissions) including responses to requests for further information from the relevant authorities.
- Post-approval activities including maintenance of approved MAs and launch activities
- Assistance in compilation of compliance files for new license approvals and updating compliance files during life cycle of the product where necessary