Senior Regulatory Affairs Specialist
4 weeks ago
Job Summary
The Senior Regulatory Affairs Specialist will be responsible for ensuring compliance with regulatory requirements for medicines, medical devices, cosmetics, and food supplements in the UK, Ireland, and Malta. This includes coordinating submissions to regulatory agencies, preparing and submitting regulatory applications, and advising on quality, preclinical, and clinical data requirements.
Key Responsibilities
- Partner with the business to deliver regulatory outcomes and enable committed business plans.
- Coordinate and submit new drug applications, cosmetics, medical devices, food supplements, or similar products to regulatory agencies.
- Prepare and submit regulatory applications according to applicable regulatory requirements and guidelines.
- Advise on regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations.
- Prioritize, plan, and monitor allocated projects against defined timelines.
- Monitor the progress of regulatory authority assessments through 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.
- Ensure all assigned products comply with local regulatory and quality system requirements.
- Monitor progress of applications against set timelines and act to minimize delays and anticipate potential risks.
- Review and approve promotional materials for assigned local Kenvue products.
- Maintain awareness of current regulations and anticipate implications and opportunities as a result of changes to the relevant regulatory environments.
- Ensure the enterprise Regulatory systems are accurate and fully maintained.
- Track the status of applications under regulatory review and provide updates to the wider Kenvue teams.
- Support the identification and 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 and maintain information resources.
- Maintain logs of communication and outcomes with regulators and other relevant internal or external stakeholders.
- Participate 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.
- Provide technical and leadership development as appropriate.
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