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Regulatory Specialist

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Regulatory Specialist managing global regulatory strategies for complex development projects in pharmaceutical industry. Coordinating regulatory submissions and ensuring high-quality deliverables throughout product lifecycle.

Posted 7/8/2026full-timeCopenhagen • 🇩🇰 DenmarkMid-LevelSeniorWebsite

About the role

Key responsibilities & impact
  • Coordinate and lead the execution of global regulatory strategies for complex development projects
  • Prepare and contribute to Clinical Trial Applications worldwide
  • Coordinate the submission of initial Marketing Authorization Applications
  • Provide regulatory expertise to cross-functional project teams
  • Build strong partnerships across the organization
  • Ensure high-quality regulatory deliverables throughout the product development lifecycle

Requirements

What you’ll need
  • A university degree in a relevant life science or medical discipline
  • At least six years of experience in Regulatory Affairs within the pharmaceutical industry
  • Hands-on experience planning and coordinating regulatory submissions
  • Solid understanding of pharmaceutical legislation, regulatory guidelines and the global regulatory environment
  • Strong communication and stakeholder management skills

Benefits

Comp & perks
  • Inspiring workplace
  • Innovative culture
  • Continuous learning
  • Open communication
  • Development opportunities focused on well-being

ATS Keywords

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Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
Regulatory Submission PlanningRegulatory Strategy ExecutionRegulatory Guidelines UnderstandingProduct Development Lifecycle Knowledge
Soft Skills
Strong CommunicationStakeholder Management