Role: EMEA Regulatory Affairs - Consultant
Duration: 5 Months
Location: High Wycombe, UK - Hybrid working (2/3 days in High Wycombe office)
KEY RESPONSIBILITIES
1. Management of post-approval activities for specified OTC products.
2. Support the EMEA Regulatory Affairs team for post-approval activities for MRP/DCP products across EEA and coordinate worksharing (WS) procedures for CMC and non-CMC variation, when WS is appropriate.
3. Development of regulatory strategies, preparation of regulatory applications and support maintenance activities for MRP/DCP products.
4. Support the team with regulatory activities for European procedures (Decentralised, Mutual Recognition, WS) as appropriate.
5. Support the team with regional regulatory strategies in line with business plan for post-approval activities.
6. Complete identified regulatory activities to ensure all regulatory obligations and business objectives are met.
7. Prepare and compile regulatory submissions (Variations, renewals, PSUSA etc.), responses to Regulatory Agency (RA) questions and other correspondence in accordance with EU regulations and guidelines.
8. Ensure Marketing Authorisations are maintained and renewed.
9. Ensure compliance within the department by ensuring EAME databases (RegPoint, HAQ) are fully maintained.
10. Adhere to processes, SOPs, working instructions and Job Aids.
11. Update relevant document repositories (e.g., CEDMS, Teams) to track current product information.
12. Support the EMEA RA team with consolidated Calls for Information (CFI) and coordinate submission of PSUSA.
13. Review and comment on consolidated CFI received from CGRRMB to ensure accurate information is sent to Aggregate Report Writer.
14. Ensure responses are submitted in a timely way in line with standard procedures and metrics set by the VP Regulatory Affairs in European Regulatory.
15. Review draft and final PSUR.
16. Coordinate submission of PSUSA and ensure on-time submission.
17. Coordinate all steps of PSUSA following its submission until CMDh position is received.
18. Coordinate submission of post-PSUSA variation across EEA as per SOP and WI.
19. Provide regulatory advice and perform due diligence for product acquisitions and distributor agreements with third parties (as appropriate).
Good Regulatory Practice
1. Maintain awareness/knowledge of current regulatory legislation.
2. Ensure regulatory best practice at all times.
3. Monitor changes in the regulatory environment and highlight any potential impact on Kenvue's products.
Customer Service
1. Act as an ambassador for the Regulatory Affairs department to raise the profile of the team both internally and externally.
2. Represent Regulatory Affairs on cross-functional product/project teams and provide regulatory advice (as appropriate).
3. Interact with Regulatory Agency.
Note: If an individual is to have full interaction with the Health Authorities and respond to submissions on behalf of Kenvue, then the HCBI due diligence process must be completed prior to having this contact.
1. Support the local colleague of the relevant country in seeking advice when appropriate.
2. Respond to requests for further information and queries.
3. Resolve any regulatory matters and expedite approval of pending applications in collaboration with the local regulatory colleague of the concerned country.
4. Provide regulatory guidance to internal stakeholders to allow them to make key decisions on business critical activities and project feasibility.
Personal Development
1. Complete induction programme in line with the defined timelines.
2. Develop product and therapeutic area knowledge as needed.
3. Ensure that any processes or SOPs/working instructions/job aids rollouts are actioned in Compliance Wire and within the defined timeline.
4. Maintain training record (as appropriate).
SKILLS, KNOWLEDGE; QUALIFICATIONS & EXPERIENCE
1. Life sciences or chemistry graduate to honours level or equivalent.
2. Work with minimal supervision to plan, conduct, and manage regulatory submissions for European procedures and multiple projects to meet department and company objectives.
3. Determine and develop approaches to solutions with technical guidance on a variety of problems of moderate scope and complexity.
4. Project management, understanding of regulatory environment, interaction with the Regulatory Authorities (as appropriate), commercial/strategic awareness, implement regulatory strategy, managing and maintaining Marketing Authorisations, etc.
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