Regulatory Affairs Consultant

Role: EMEA Regulatory Affairs Consultant

Duration: 5 Months

Location: High Wycombe, UK - Hybrid working (2 /3 days in High Wycombe office)

KEY RESPONSIBILITIES

Management of post-approval activities for specified OTC products

• Supports 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.

Development of regulatory strategies, preparation of regulatory applications and support maintenance activities for MRP/DCP products

• Supports the team with regulatory activities for European procedures (Decentralised, Mutual Recognition, WS) as appropriate.

• Supports the team with regional regulatory strategies in line with business plan for post-approval activities.

• Supports the team to complete identified regulatory activities to ensure all regulatory obligations and business objectives are met.

• Prepares and compiles regulatory submissions (Variations, renewals, PSUSA etc.), responses to Regulatory Agency (RA) questions and other correspondence in accordance with EU regulations and guidelines.

• Ensure Marketing Authorisations are maintained and renewed.

• Ensures compliance within the department by ensuring

• EAME databases (RegPoint, HAQ) are fully maintained.

• Processes, SOPs, working instructions and Job Aids are adhered to.

• Update relevant document repositories (e.g CEDMS, Teams etc.) to track current product information.

• Supports the EMEA RA team with consolidated Calls for Information (CFI) and coordinate submission of PSUSA

• Review and comment consolidated CFI received from CGRRMB to ensure accurate information is sent to Aggregate report writer.

• Ensure responses are submitted in a timely way in line with standard procedures and metrics set by the VP Regulatory Affairs in European Regulatory.

• Review draft and final PSUR.

• Coordinate submission of PSUSA and ensure on-time submission

• Coordinate all steps of PSUSA following its submission until CMDh position is received

• Coordinate submission of post-PSUSA variation across EEA as per SOP and WI.

• Provides regulatory advice and performs due diligence for product acquisitions and distributor agreements with third parties (as appropriate).

Good Regulatory Practice

• Maintain awareness/knowledge of current regulatory legislation

• Ensures regulatory best practice at all times.

• Monitor changes in the regulatory environment and highlight any potential impact on Kenvue’s products.

Customer Service

• May act as an ambassador for the Regulatory Affairs department to raise profile of team both internally and externally.

• May represent Regulatory Affairs on cross-functional product/project teams and provides regulatory advice (as appropriate).

• Interactions 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 an individual having this contact.

• Support the local colleague of the relevant country in seeking advice when appropriate.

• Respond to requests for further information and queries.

• Resolve any regulatory matters and expedite approval of pending applications in collaboration with the local regulatory colleague of the concerned country.

• Provides regulatory guidance to internal stakeholders, to allow them make key decisions on business critical activities and project feasibility.

Personal Development

• Complete induction programme in line within the defined timelines.

• Develop product and therapeutic area knowledge as needed.

• Ensure that any processes or SOPs/working instructions/ job aids roll outs are actioned in Compliance Wire and within the defined timeline.

• Maintains training record (as appropriate).

SKILLS, KNOWLEDGE; QUALIFICATIONS & EXPERIENCE

• Life sciences or chemistry graduate to honours level or equivalent.

• Works with minimal supervision to plan, conduct, and manage regulatory submissions for European procedures and multiple projects to meet department and company objectives.

• Work with minimal supervision to determine and develop approaches to solutions with technical guidance on a variety of problems of moderate scope and complexity.

• 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