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Regulatory Affairs Manager

2 weeks ago

Stockholm, Stockholm, Sweden TN Sweden Full time

TN Sweden seeks a Regulatory Affairs Manager to join our Medical department. This dedicated and committed team is expanding, with the role reporting to the Head of Regulatory Affairs, Quality Assurance, and Pharmacovigilance.

The successful candidate will enjoy working in a small, fast-moving company with an agile approach and strong employee culture. A positive attitude, open-mindedness, and effective communication skills are essential for success in this role.

Main Responsibilities:

  1. Regulatory Strategy Development:
  • Supports the organization with regulatory strategic knowledge.
  • Assists with the development of standards for operating procedures.
Policy Monitoring:
  • Stays up-to-date with relevant regulations and provides recommendations to leadership.
  • Supports implementation of new requirements accordingly.
Cross-functional Collaboration:
  • Reviews and manages internal approval of marketing material from a regulatory perspective.
Communication with External Partners:
  • Main contact for partner companies and competent authorities on regulatory matters for medicinal products and medical devices.
  • Prepares and submits applications and reports to applicable regulatory agencies as requested.
  • Assists with linguistic and regulatory review of product texts and artwork.

Qualifications & Skills:

  • MSc of Pharmacy or other relevant degree in natural sciences.
  • Minimum 2 years of experience in Regulatory Affairs.
  • 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 English.
  • Merit: Experience from both MedTech and pharmaceutical industry.