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Regulatory Affairs Director

2 weeks ago

Stockholm, Stockholm, Sweden TN Sweden Full time

We are seeking a highly skilled Team Lead Pharma Submissions & Compliance, Global Regulatory Affairs to join our team in Stockholm, Sweden. As a member of our Regulatory Affairs team, you will be responsible for managing a team to drive maintenance and development of Karo medicinal products.

Key Responsibilities:

The successful candidate will be responsible for developing and implementing strategies for Submissions & Compliance activities, ensuring timely submission planning and performance, and managing regulatory procedures and associated regulatory tasks for assigned portfolio.

The ideal candidate will have a strong understanding of regulatory requirements and applicable legal frameworks, as well as excellent communication skills with the ability to look at issues from different angles.

Requirements:

  • University degree in Life Science
  • Minimum 5 years experience in Global Regulatory Affairs
  • Formal or informal leadership qualities
  • Extensive record of Variation management
  • Experience from artwork maintenance and associated label requirements

Our Company Culture:

  • Diverse & Inclusive environment
  • Dynamic, international, and motivated team
  • Opportunity to create, grow, and encourage