Regulatory Affairs Specialist

7 days ago

Solna Municipality, Sweden Kenvue Full time
Regulatory Affairs Associate

Kenvue is seeking a highly skilled Regulatory Affairs Associate to join our team in Stockholm. As a key member of our Regulatory Affairs department, you will be responsible for overseeing a range of regulatory activities for our medicines, medical devices, cosmetics, and food supplements.

Key Responsibilities:
  • Assist in the coordination, compilation, and submission of new drug applications, cosmetics, medical devices, food supplements, or any similar product to the regulatory agencies within our geographical and/or brand area of responsibility.
  • Collect and organize information on regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations.
  • Prepare and submit regulatory submissions according to applicable regulatory requirements and guidelines.
  • Monitor the progress of the regulatory authority review process through appropriate communication with the Health Authority.
  • Prioritize, plan, and monitor allocated projects against defined timelines.
  • Develop and maintain a thorough understanding of the regulatory environment and supporting data requirements.
Regulatory Compliance:
  • Assist in the maintenance of compliance for all products with local regulations and quality system requirements.
  • Ensure that all assigned products comply with local regulatory and quality system requirements.
  • Review and approve promotional materials for assigned local Kenvue products.
  • Initiate, review, and approve new or revised product artworks in collaboration with Cluster Artwork Coordinator.
  • Assist in ensuring that the enterprise Regulatory systems are accurate and fully maintained.
  • Identify and initiate local process improvement opportunities and manage changes as required.
  • Assist in the preparation for internal and external audits and inspections in collaboration with others.
Qualifications:
  • Relevant Bachelor's Degree or higher.
  • 2+ years of related regulatory experience.
  • Knowledge of consumer healthcare environment and product development.
  • Understanding of processes and departments within a healthcare company.
  • Effective time and organization management.
  • Full proficiency in both Swedish and English.

Kenvue offers a competitive Total Rewards Package, Paid Company Holidays, Paid Vacation, Volunteer Time, and more. We also provide Learning & Development Opportunities, Employee Resource Groups, and a dynamic work environment that fosters growth and innovation.

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