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Senior Manager Regulatory Affairs - Nordics

Senior Manager Regulatory Affairs - Nordics

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Senior Manager Regulatory Affairs - Nordics

  • Location:

    Sweden

  • Sector:

    Regulatory Affairs - Pharma

  • Contact:

    Glen Fairbrother

  • Salary:

    Negotiable

  • Job type:

    Permanent - full time

  • Contact email:

    glenf@msipharma.com

  • Job ref:

    SRAMGGF_1718187731

  • Published:

    about 1 month ago

  • Duration:

    Permanent

  • Startdate:

    Oct/Oct - ASAP

We are seeking a dynamic and experienced professional to join our client's team as the Senior manager of Regulatory Affairs for The Nordics (Sweden). Based in the Stockholm area, you will work in a Hybrid work environment. The Senior Manager of Regulatory Affairs (RA) is a country expert with an in-depth understanding of the regulatory environment within their geographical area of responsibility as well as requirements and strategies for regulatory submissions, approval pathways and compliance activities and the potential impact of these on business objectives.

Key Responsibilities:

  • Guide product development teams to ensure compliance with local regulatory requirements.
  • Assess documentation for regulatory submission and support proposed product claims.
  • Prepare and submit regulatory filings, monitoring progress through the review process.
  • Stay updated on current regulations and communicate changes to relevant stakeholders.
  • Ensure all products comply with local regulations and quality standards.
  • Review and approve promotional materials and product artwork.
  • Manage internal and external audits and inspections.
  • Identify opportunities for process improvement and implement initiatives.

Specific Requirements:

  • Bachelor's degree or higher.
  • 8+ years of regulatory experience.
  • Expertise in various regulatory classifications (e.g., medicinal products, cosmetics, medical devices).
  • Leadership and coaching skills.
  • Proficiency in English.

Essential Knowledge and Skills:

  • Excellent knowledge of regulatory frameworks within Sweden.
  • Strong leadership and coaching abilities.
  • Understanding of the consumer healthcare environment and product development.
  • Ability to work in a multi-cultural, matrixed organisation.

Why Join our client

As a world-leading consumer health company and play a pivotal role in shaping the future of healthcare through innovative regulatory strategies. As the Senior Manager of Regulatory Affairs, you'll lead a team and contribute to the success or the Nordics market. If you're a visionary leader passionate about regulatory affairs and committed to excellence, this could be the ideal role.

Please Send your latest resume and a cover letter outlining your experience and vision for the role or call me on 02079401985 if you require further information