Head of Regulatory Affairs and Compliance

1 day ago


Stockholm, Stockholm, Sweden PharmaRelations ApS Full time
Leadership Opportunity

As Senior Director Regulatory Affairs, you will have the opportunity to lead regulatory activities, develop and implement strategies, and collaborate with the global team. You will take ownership of regulatory activities, overseeing marketing and ensuring compliance.

Accountabilities
  • Take ownership of regulatory activities, including MAs, marketing of cosmetics, medical devices, and food supplements.
  • Collaborate with the global team to develop and implement regulatory strategies tailored to the Nordic region.
  • Evaluate submission packages to meet Nordic regulatory standards, eliminating deficiencies prior to submission.
  • Monitor and influence the assessment process to expedite approvals and optimize outcomes.
Requirements
  • Broad regulatory experience in medicinal products, preferably with a focus on OTC products and commercial aspects within the pharmaceutical industry.
  • Minimum 10 years in regulatory activities with a proven track record of leadership and negotiation skills.
  • Knowledge of promotional compliance and best practices, as well as proficiency in English and a Nordic language.


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