Senior Regulatory Affairs Specialist – Self Care-2407022637W
Description
Kenvue is currently recruiting for:
Senior Regulatory Affairs Specialist – Self Care
The Senior Regulatory Affairs Specialist is responsible for a range of regulatory activities for their assigned medicines, medical devices, cosmetics and/or food supplement consumer products within UK, Ireland and Malta. Activities 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. This position reports into the Senior Manager/Manager Regulatory Affairs and is based at High Wycombe (hybrid).
Who We Are
At , 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 up with 22,000 diverse and brilliant people, passionate about insights, innovation and committed to deliver the best products to our customers. With expertise and empathy, being a Kenvuer means to have the power to impact 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. For more information, .
What You Will Do
·Partner with the business to deliver regulatory outcomes to enable committed business plans within area of responsibility.
·Coordinate, compile & submit new drug applications, cosmetics, medical devices, food supplements or any similar product to the regulatory agencies within UK, Ireland, and Malta within area of responsibility.
·Prepare and submit regulatory applications according to applicable regulatory requirements and guidelines.
·Initiate, review, and approve new or revised product artworks in collaboration with Cluster Artwork Coordinator.
·Advise on regulatory requirements for quality, preclinical and clinical data to meet applicable regulations.
·Prioritize, plan and monitors allocated projects against defined timelines.
·Monitor the progress of the regulatory authority assessment through appropriate communication with the Health Authority.
·Develop and maintain a thorough understanding of the regulatory environment and supporting data requirements.
·Participate in trade association working groups, and support the development of impact assessments, influencing strategies, and leading solutions at a local level (if relevant).
·Ensure all assigned products comply with local regulatory and quality system requirements.
·Monitors progress of applications against set timelines, acting where necessary to minimize delays and anticipate potential risks.
·Review and approve promotional materials for assigned local Kenvue products (if relevant).
·Maintain awareness of current regulations and anticipate implications and opportunities as a result of changes to the relevant regulatory environments.
·Ensure that the enterprise Regulatory systems are accurate and fully maintained.
·Track the status of applications under regulatory review and provides updates to the wider Kenvue teams.
·Support the identification & initiation of local process improvement opportunities and manage changes as required.
·Ensure any compliance issues are reviewed and escalated and relevant corrective/preventative actions are implemented locally.
·Monitor the regulatory environment (specific regulations, guidance and other relevant information by product types, geography, etc.) and maintain information resources.
·Maintain logs of communication and outcomes with regulators and other relevant internal or external stakeholders.
·Participates in the development and implementation of, and maintain compliance with, all applicable Processes, SOPs and working instructions.
·Identify and/or implement local/regional process improvement opportunities and ensure implementation of relevant global or regional regulatory initiatives.
·Support internal and external audits and inspections in collaboration with relevant function.
·Provides technical and leadership development as appropriate.
Qualifications
Primary Location
Europe/Middle East/Africa-United Kingdom-England-High Wycombe
Job Function
Regulatory Affairs
