Director of Compliance and Regulation

2 days ago


Stockholm, Stockholm, Sweden PharmaRelations ApS Full time
Job Description

We are seeking a highly skilled Senior Director Regulatory Affairs to join our team at PharmaRelations ApS. In this role, you will be responsible for establishing and leading regulatory activities across various areas.

Main Responsibilities
  • Develop and implement regulatory strategies tailored to the Nordic region, collaborating with the global team and local colleagues.
  • Evaluate submission packages to meet Nordic regulatory standards, ensuring compliance and eliminating deficiencies prior to submission.
  • Monitor and influence the assessment process to expedite approvals and optimize outcomes, including product labeling and supply continuity.
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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