Global Regulatory Submissions Specialist

Pharmacosmos; Holbæk; Hybrid; DKK 420,000 - 650,000; Full time

Job summary

Pharmacosmos is seeking an experienced Regulatory Affairs Coordinator to join its Regulatory Affairs team in Denmark. The role focuses on global regulatory operations, including eCTD submissions, regulatory publishing, and lifecycle management across international markets.

The ideal candidate will have hands-on experience with Veeva RIMS, including implementation or user training, and strong expertise in preparing and submitting eCTD dossiers.

Qualifications

• Educational background in life sciences with regulatory affairs experience.
• Hands-on with Veeva RIMS, including implementation or user training.
• Experience preparing, validating and submitting eCTD dossiers globally.

Responsibilities

• Support global regulatory operations, including submission planning and document handling.
• Assist with Veeva RIMS implementation, maintenance and user training.
• Prepare, validate and submit regulatory dossiers in eCTD format across markets.
• Ensure submission readiness and high-quality regulatory data.
• Support product roll-out and lifecycle management of marketing authorisations.

Skills

Regulatory affairs

Veeva RIMS

eCTD submissions

Document handling

Life-cycle management

Regulatory publishing

IT/data quality

Cross-functional collaboration

Education

Life sciences degree

Tools

Veeva RIMS

Job description

Pharmacosmos is seeking an experienced Regulatory Affairs Coordinator to join its Regulatory Affairs team in Denmark. The role focuses on global regulatory operations, including eCTD submissions, regulatory publishing, and lifecycle management across international markets.

The ideal candidate will have hands-on experience with Veeva RIMS, including implementation or user training, and strong expertise in preparing and submitting eCTD dossiers.