Senior Regulatory Affairs Specialist

Vor 7 Tagen

Neuss, Nordrhein-Westfalen, Deutschland Kenvue Vollzeit
About the Role

We are seeking a highly skilled Senior 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
  • Regulatory Strategy
    • Develop global and/or regional regulatory strategies, coordinating regulatory actions and results
    • Provide regulatory advice and perform due diligence for product acquisitions and distributor agreements
    • Organize materials from preclinical and clinical studies for review and assist in the review process
    • 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
  • Regulatory Compliance
    • Maintain logs of communication and outcomes with regulators and other relevant internal or external stakeholders
    • 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
    • Ensure any compliance issues are reviewed and escalated and relevant corrective/preventative actions are implemented locally
    • Identify and/or implement regional process improvement opportunities and ensure implementation of relevant global or regional regulatory initiatives
    • Support internal and external audits and inspections in collaboration with quality function
  • Regulatory Advocacy
    • Monitor the regulatory environment (specific regulations, guidance and other relevant information by product types, geography, etc.) and maintain information resources
    • Support in trade association, working groups, developing impact assessments, influencing strategies, and leading solutions at EU and local level (if relevant)
  • Team Management
    • Provide technical and leadership development as appropriate
    • Monitor progress of applications of self against set timelines, acting where necessary to minimize delays and anticipate difficulties
Requirements

To be successful in this role, you will need to have a strong background in regulatory affairs, with experience in developing and implementing regulatory strategies. You will also need to have excellent communication and project management skills, as well as the ability to work effectively in a team environment.

We offer a competitive salary and benefits package, as well as opportunities for professional development and growth. If you are a motivated and experienced regulatory affairs professional looking for a new challenge, please submit your application.

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