Regulatory Affairs Specialist with Lifecycle Management Expertise

4 days ago

Copenhagen, Copenhagen, Denmark F. Hoffmann-La Roche Gruppe Full time

At F. Hoffmann-La Roche Gruppe, we're pushing the boundaries of healthcare with over 100,000 employees across 100 countries.

About the Role

We're looking for a highly motivated and organized Regulatory Affairs Partner to join our team in Denmark or Iceland. As a key member of our regulatory team, you will play a critical role in driving regulatory tasks and making a significant impact on our business.

This challenging and varied job offers independent responsibility for driving regulatory submissions, including new product approvals and lifecycle management initiatives. You'll work closely with our QA and compliance teams to ensure seamless execution of regulatory tasks.

Main Responsibilities:

  • Be regulatory responsible for assigned products in Denmark and Iceland.
  • Coordinate and prepare document packages for regulatory submissions, including new product approvals and lifecycle management initiatives.
  • Proofread regulatory texts in local language.
  • Responsible for artworks changes related to Lifecycle Management, including manuscript creation, proofreading, and approval.
  • Ensure corporate regulatory data and document management systems are up-to-date.
  • Stay abreast of regulatory legislations, procedures, and changes to the regulatory landscape to secure compliance at all times.
  • Interact directly with regulatory agencies.
  • Support the business and disease area teams with regulatory details, timelines, and information related to products.
  • Work with Roche HQ to coordinate and support Scientific Advises with the Danish Health Authorities.
  • Implement new systems and train new colleagues.
  • Maintenance of procedures to secure compliance to regulatory legislation.

Requirements:

  1. You hold a Master's degree in pharmacy, pharmaceutical sciences, or related fields.
  2. You have strong personality traits and thrive working in a regulated environment.
  3. You're systematic in your approach, flexible, and possess excellent interpersonal skills.
  4. You're a team player, able to work independently and effectively collaborate with others.
  5. You can express yourself effectively in Danish and English, both spoken and written.

With a competitive salary of around €60,000 - €80,000 per year, plus additional benefits, this is an excellent opportunity to grow your career in a dynamic and innovative company.

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