MAIN PURPOSE OF ROLE:
Provide regulatory support and expertise for the EU portfolio.
Work cross-functionally and in collaboration with key stakeholders/customers both internal (e.g. commercial, technical, quality, medical, supply chain etc.) and external (e.g. local regulatory partners, local distributors and MA holders, regulatory agencies, CMOs).
Act as contact point/knowledge base for scientific & technical aspects of module 1 (administrative including labelling) and module 3 (CMC - chemistry, manufacture and control) documents and associated regulatory activities.
Management of allocated product portfolio.
KEY RESPONSIBILITIES AND ACCOUNTABILITIES:
- Timely filing of complete, high quality regulatory submissions; prompt, complete and accurate responses to RFIs (requests for further information) received from regulatory agencies and effective communication of approvals.
- Variation applications
- Renewal applications
- PSUR submissions
- Sunset clause exemptions
- Notifications, e.g. MA transfers, MA cancellations
- MA applications when applicable
- Ensure that all submissions comply with the current regulatory guidelines and legislation at all times. When required, high quality module 3 document writing for applications for submission to regulatory authority.
- 100% accurate and complete recording of all regulatory submissions and approvals, correspondence with regulatory agencies and any associated log.
- Ensuring that regulatory document management system contains the most current and accurate information.
- Assessing changes received from regulatory perspective ensuring transparency with regard to submission category, documents required and approval timelines.
- Ensuring that all product information (SmPC, PIL, labelling) is updated when required, submitted to regulatory agencies and subsequently approved artwork is accurately recorded and communicated for implementation. Ensuring that appropriate translations to local language and back-translations are made.
- Timely meeting of training targets & learning objectives.
- Implementing and complying with current SOPs and Work Instructions.
- Planning & management of all allocated projects and ensuring timely delivery of these projects.