Regulatory Specialist

Copenhagen, Capital Region
Posted 3 days, 4 hours ago
Healthcare

About the role

Job summary

The role involves managing global regulatory strategies for complex development projects within the pharmaceutical industry, focusing on brain disorders. You will collaborate with cross-functional teams to ensure high-quality regulatory deliverables throughout the product lifecycle.

Qualifications

  • University degree in a relevant life science or medical discipline.
  • Minimum of six years of experience in Regulatory Affairs in the pharmaceutical sector.

Responsibilities

  • Coordinate and lead the execution of global regulatory strategies.
  • Prepare and contribute to Clinical Trial Applications and initial Marketing Authorization Applications.
  • Provide regulatory expertise to project teams and build partnerships across the organization.

Skills

  • Strong communication and stakeholder management skills.
  • Ability to navigate complex regulatory challenges.

Education

  • Relevant university degree in life sciences or medical discipline.

Tools

  • Familiarity with pharmaceutical legislation and regulatory guidelines.
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