Regulatory Affairs Expert

2 days ago


Stockholm, Stockholm, Sweden TN Sweden Full time
Job Description

TN Sweden is seeking a highly motivated and detail-oriented Regulatory Affairs Manager to join our expanding Regulatory, QA & PV team within the Medical department.

This role will provide an exciting opportunity for you to utilize your knowledge of regulatory and marketing compliance in a dynamic environment. As a key member of our team, you will be responsible for developing regulatory strategies that support the organization's growth and compliance with relevant regulations.

Key Responsibilities:

  1. Developing Regulatory Strategies:
    • Support the development of regulatory strategic knowledge to ensure compliance with applicable laws and regulations.
    • Assist in developing standards for operating procedures to ensure consistency and efficiency.
  2. Policy Monitoring and Implementation:
    • Stay up-to-date with relevant regulations and provide recommendations to the leadership team on policy implementation.
    • Support the implementation of new requirements accordingly.
  3. Cross-functional Collaboration:
    • Review and manage internal approval of marketing material from a regulatory perspective (approximately 60% of the workload during peak periods).
  4. Communication with External Partners:
    • Serve as the primary contact for partner companies and competent authorities on regulatory matters for medicinal products and medical devices.
    • Prepare and submit applications and reports to applicable regulatory agencies as needed.
    • Respond to requests for information from regulatory bodies.
    • Assist manufacturers with local linguistic and regulatory review of product texts (SPC and PIL) and artwork.

Requirements and Qualifications:

  • MSc of Pharmacy or other relevant degree in natural sciences.
  • Minimum 2 years of experience in Regulatory Affairs.
  • 2-5 years' experience in marketing compliance.
  • Strong knowledge of regulations for medicinal products and/or medical devices.
  • Excellent communication and interpersonal skills.
  • Proven ability to lead regulatory submissions and interactions with regulatory agencies.
  • Fluent in Swedish and English.
  • Merit: Experience from both MedTech and the pharmaceutical industry.


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