Regulatory Affairs Specialist
4 weeks ago
At Kenvue, we are seeking a highly skilled Regulatory Affairs Specialist to oversee a range of regulatory activities for our assigned medicines, medical devices, cosmetics, and/or food supplement consumer products within the UK, Ireland, and Malta.
The successful candidate will be responsible for compiling and submitting applications, resolving Health Authority questions, and managing post-approval commitments and submission of variations/renewal applications.
This role reports into the Associate Director Regulatory Affairs and is based at High Wycombe, with a hybrid working arrangement.
We are a global team of 22,000 diverse and brilliant people, passionate about insights, innovation, and committed to delivering the best products to our customers.
The ideal candidate will have a strong understanding of regulatory requirements and guidelines, as well as excellent communication and project management skills.
Key responsibilities include:
- Assisting in the coordination, compilation, and submission of new drug applications, cosmetics, medical devices, food supplements, or any similar product to the regulatory agencies within the UK, Ireland, and Malta.
- Collecting and organizing information on regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations.
- Preparing and submitting regulatory submissions according to applicable regulatory requirements and guidelines.
- Monitoring the progress of the regulatory authority review process through appropriate communication with the Health Authority.
- Prioritizing, planning, and monitoring allocated projects against defined timelines.
- Developing and maintaining a thorough understanding of the regulatory environment and supporting data requirements.
- Assisting in the maintenance of compliance for all products with local regulations and quality system requirements.
- Ensuring that all assigned products comply with local regulatory and quality system requirements.
- Reviews and approves promotional materials for assigned local Kenvue products (if relevant).
- Initiates, reviews, and approves new or revised product artworks in collaboration with Cluster Artwork Coordinator.
- Monitors progress of applications against set timelines, acting where necessary to minimize delays and anticipate difficulties.
- Assists in ensuring that the enterprise Regulatory systems are accurate and fully maintained.
- Tracks the status of applications under regulatory review and provides updates to the wider Kenvue teams.
- Assists in the identification and initiation of local process improvement opportunities and manages changes as required.
- Assists in the preparation for internal and external audits and inspections in collaboration with others.
- Assists and ensures compliance issues are reviewed and escalated and relevant corrective/preventative actions are implemented locally.
- Assists in trade association, working groups, developing impact assessments influencing regulatory strategies, and leading solutions at a local level (if relevant).
- Partners with the business to deliver regulatory outcomes to enable committed business plans within area of responsibility.
- Participates in the development and implementation of, and maintain compliance with, all applicable Processes, SOPs, and working instructions.
Qualifications
Primary Location: Europe/Middle East/Africa-United Kingdom-England-High Wycombe
Job Function: Regulatory Compliance
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