Come work at the forefront of science - and help the brands you grew up with grow and evolve into the next generation.
Job Description - Regulatory Affairs Specialist UK & Ireland (2507029881W)
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 Brand Adhesive Bandages that you already know and love. Science is our passion; care is our talent. Our global team is made up of ~ 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 having the power to impact the life 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.
Job Purpose
The Regulatory Affairs Specialist is accountable for all regulatory activities associated with their assigned medicines, medical devices, cosmetics and/or food supplement consumer products within their geographical and/or brand area of responsibility. Projects may include compilation and submission of applications (post approval and new submissions), resolution of Health Authority questions in cooperation with other functions, post-approval commitments and submission of variations/renewal applications where requested.
Essential duties and responsibilities
Regulatory Strategy
* Assists in 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.
* Collects and evaluates information on regulatory requirements for quality, preclinical and clinical data to meet applicable regulations.
* 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, seeking opportunities to expedite regulatory approvals where possible.
* Prioritizes, plans and monitors allocated projects against defined timelines.
* Develops and maintains a thorough understanding of the regulatory environment and supporting data requirements.
Regulatory Compliance
* Ensures that all assigned products comply with local regulatory and quality system requirements.
* Reviews and approves promotional materials for assigned local Kenvue products.
* Initiates, reviews and approves new or revised product artworks in collaboration with Cluster Artwork Coordinator.
* Assists in ensuring that the enterprise Regulatory systems are accurate and fully maintained.
* Identifies & initiates local process improvement opportunities and manage changes as required.
* Assists in the preparation for internal and external audits and inspections in collaboration with others.
Job Requirements
* Relevant Bachelor's Degree or higher.
* 4+ years related regulatory experience.
* Knowledge of consumer healthcare environment and product development.
* Understanding of processes and departments within a healthcare company.
* Effective time and organization management.
* Excellent communication skills, with the ability to articulate and express concepts clearly both verbally and in writing, particularly when simplifying complex regulatory or technical issues.
* Good interpersonal skills; able to build effective personal networks internally and externally.
* Collaborative with a strong sense of ownership, willing to be held accountable and be rewarded for delivering results.
* Strong organizational and time management skills with an ability to work under pressure.
* Able to work effectively in a multi-cultural, highly matrixed organization.
* Proficiency in English.
Primary Location
Europe/Middle East/Africa-United Kingdom-England-High Wycombe
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