Kenvue is currently recruiting for a:
Senior Regulatory Affairs Specialist
This position reports into a Regulatory Affairs Manager and is based at High Wycombe (hybrid).
Who We Are
At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including NEUTROGENA, AVEENO, TYLENOL, LISTERINE, JOHNSON’S and BAND-AID that you already know and love. Science is our passion; care is our talent. Our global team is made by 22,000 diverse and brilliant people, passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means to have the power to impact the lives of millions of people every day. 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 OTC in the UK, Ireland, and Malta. You will develop regulatory strategies, prepare regulatory applications, and support maintenance activities within the relevant therapy area.
* Ensures the success of new product registrations, line extensions, and new indications and claims in alignment with the business plan.
* Manages the coordination, compilation, and submission of new drug applications, cosmetics, medical devices, food supplements, or any similar product to the regulatory agencies within their geographical and/or brand area of responsibility.
* Maintains compliance for all products with local regulations and quality system requirements.
Key Responsibilities Include:
Regulatory Strategy
* Works independently to provide regulatory input and technical guidance on local regulatory requirements to product development teams.
* Assesses the acceptability of quality, preclinical, and clinical documentation for submission filing to comply with applicable local Health Authority requirements, where relevant.
* Provides regulatory assessment and guidance for proposed product claims/labeling, ensuring that the provided clinical and non-clinical data are consistent with the local regulatory requirements and support the proposed product classification and claims.
* Prepares and submits regulatory submissions according to applicable regulatory requirements and guidelines.
* Monitors the progress of the regulatory authority review process through appropriate communication with the Health Authority.
* Familiarizes and understands the current regulatory legislation to keep the legislative knowledge up to date at local and regional levels.
Regulatory Compliance
* Maintains awareness of current regulations and anticipates implications and opportunities as a result of changes to the relevant regulatory environments. Communicates changes to appropriate management and cross-functional experts as appropriate and implements locally.
* Ensures that all products comply with local regulatory and quality system requirements.
* Participates in the development and implementation of, and maintains compliance with, all applicable Processes, SOPs, and working instructions.
* Reviews and approves promotional materials for assigned local Kenvue products and assists in claim support.
* Initiates, reviews, and approves new or revised product artworks in collaboration with Cluster Artwork Coordinator.
* Ensures that the enterprise Regulatory systems are accurate and fully maintained.
* Ensures any compliance issues are reviewed and escalated, and relevant corrective/preventative actions are implemented locally.
* Identifies local process improvement opportunities and ensures implementation of relevant global or regional regulatory initiatives.
* Supports internal and external audits and inspections in collaboration with the quality function.
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