Regulatory Affairs Specialist

3 weeks ago


Solna Municipality, Sweden Kenvue Full time

Regulatory Affairs Associate

This role is responsible for overseeing regulatory activities for assigned medicines, medical devices, cosmetics, and/or food supplements within their geographical and/or brand area of responsibility.

Key Responsibilities

  • Assists in the coordination, compilation, and submission of new drug applications, cosmetics, medical devices, food supplements, or any similar product to the regulatory agencies within their geographical and/or brand area of responsibility.
  • Collects and organizes information on regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations.
  • Prepares and submits regulatory submissions according to applicable regulatory requirements and guidelines.
  • Monitors the progress of the regulatory authority review process through appropriate communication with the Health Authority.
  • Prioritizes, plans, and monitors allocated projects against defined timelines.
  • Develops and maintains a thorough understanding of the regulatory environment and supporting data requirements.

Regulatory Compliance

  • Assists in the maintenance of compliance for all products with local regulations and quality system requirements.
  • Ensures that all assigned products comply with local regulatory and quality system requirements.
  • Reviews and approves promotional materials for assigned local Kenvue products.
  • Initiates, reviews, and approves new or revised product artworks in collaboration with Cluster Artwork Coordinator.
  • Assists in ensuring that the enterprise Regulatory systems are accurate and fully maintained.
  • Identifies and initiates local process improvement opportunities and manages changes as required.
  • Assists in the preparation for internal and external audits and inspections in collaboration with others.

Qualifications

  • Relevant Bachelor's Degree or higher.
  • 2+ years 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.


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