Regulatory Affairs Specialist
4 weeks ago
This position reports into a Regulatory Affairs Manager and is based at High Wycombe (hybrid). 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. care is our talent. You will look into the development of regulatory strategies, preparation of regulatory applications and support maintenance activities within 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, 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.
- 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.
- Maintains awareness of current regulations and anticipates implications and opportunities as a result of changes to the relevant regulatory environments.
- Ensures that all products comply with local regulatory and quality system requirements.
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