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Description

Kenvue is currently recruiting for a: Senior Regulatory Affairs Executive - Northern Cluster

Who We Are

We put people first, care fiercely, earn trust with science and solve with courage – and have brilliant opportunities waiting for you! Join us in shaping our future–and yours.

What You Will Do

In this role, you will be responsible for the management of a number of products within a therapy area for Cosmetics, OTC and/or Medical Devices in the UK, Ireland and Malta. You will look into the development of regulatory strategies, preparation of regulatory applications and support maintenance activities within relevant therapy area.

Key responsibilities include:

• Support regulatory activities for National and European procedures (Decentralised, Mutual Recognition) as appropriate.
• Develop and support regulatory strategies (local and regional) in line with business plan.
• Complete regulatory activities for a defined number of products to ensure all regulatory obligations and business objectives are met:
• Prepares and compiles regulatory submissions (Marketing Authorisations, Reclassifications etc.), responses to Regulatory Agency (RA) questions and other correspondence in accordance with EU regulations and guidelines.
• Sign off of packaging material, leaflets, Sm PCs and advertising material to ensure regulatory compliance for submissions via Zinc, COCOON, Starfish systems etc.
• Ensure Marketing Authorisations are maintained and renewed.
• Inform the Regulatory Agency/Department of Health (as appropriate) of product discontinuations and licence cancellations.
• Ensures compliance within the department by ensuring:
• Global, EAME and local databases are fully maintained.
• Processes, SOPs and working instructions are adhered to.
• Update relevant local and global databases (e.g Documentum, Aris, GLR, Connect etc.) to track current product information.
• Provide regulatory advice and perform due diligence for product acquisitions and distributor agreements with third parties.
• Ensures regulatory best practice at all times.
• Monitor changes in the regulatory environment and highlight any potential impact.
• Represent Regulatory Affairs on cross-functional product/project teams and provides regulatory advice (as appropriate).
• Interact with Regulatory Agency.
• Provide regulatory guidance to internal stakeholders, to allow them make key decisions on business critical activities and project feasibility.
• Represent J&J and provide regulatory advice at e.g. joint Company/Trade Association initiatives, Regulatory Agency meetings etc (as appropriate).

Qualifications

What we are looking for

The successful individual will have excellent business partnering, analytical and communication skills.

You will have initial experience within the Regulatory Affairs environment supporting OTC or Cosmetics and be able to demonstrate the following:

• Life sciences or chemistry graduate to honours level or equivalent.
• Works independently to plan, conduct, and manage regulatory submissions 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.
• May mentor Regulatory Executives and provide day to day support.
• Project management, understanding of regulatory environment, interaction with the Regulatory Authorities, commercial / strategic awareness, implement regulatory strategy, managing and maintaining Marketing Authorisations.
• Ability to shape plans and connect with the wider organization.
• Deliver on key KPI commitments.

• Competitive Benefit Package
• Paid Company Holidays, Volunteer Time, option to buy and sell holiday
• Learning & Development Opportunities
• Employee Resource Groups

Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identify, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Job Function Regulatory Affairs