Regulatory Affairs Specialist
2 months ago
We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Kenvue. As a key member of our Regulatory Affairs department, you will be responsible for developing and implementing regulatory strategies across the EMEA region and globally.
Key Responsibilities- Develop and implement global and regional regulatory strategies, coordinating regulatory actions and results.
- Organize and review materials from preclinical and clinical studies, and prepare and submit regulatory submissions according to applicable regulatory requirements and guidelines.
- Assist in the scheduling of meetings with internal stakeholders and regulators, and develop and organize materials for these meetings.
- Track the status of applications under regulatory review and provide updates to the regulatory team.
- Maintain awareness of current regulations and anticipate implications and opportunities as a result of changes to the relevant regulatory environments.
- Participate in the development and implementation of, and maintain compliance with, all applicable processes, SOPs, and working instructions.
- Ensure that the enterprise Regulatory systems are accurate and fully maintained.
- Support internal and external audits and inspections in collaboration with the quality function.
- Monitor the regulatory environment and maintain information resources.
- Support trade association, working groups, developing impact assessments, influencing strategies, and leading solutions at EU and local level.
- Provide technical and leadership development as appropriate.
To be successful in this role, you will need:
- Strong knowledge of regulatory requirements and guidelines.
- Excellent communication and project management skills.
- Ability to work independently and as part of a team.
- Strong analytical and problem-solving skills.
- Ability to prioritize tasks and manage multiple projects simultaneously.
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