Global Regulatory Submissions Specialist - eCTD & Veeva

Pharmacosmos; Hvidovre Kommune; On-site; DKK 600,000 - 900,000; Full time

Job summary

Pharmacosmos is seeking an experienced Regulatory Affairs Coordinator to join our Regulatory Affairs department. The role supports global regulatory operations, including eCTD submissions, regulatory publishing, and lifecycle activities across international markets.

The successful candidate will have hands-on experience with Veeva RIMS, expertise in preparing and submitting eCTD dossiers, and a proactive approach to data quality and process improvement.

Qualifications

• Hold a relevant educational background within life sciences or a related field.
• Have hands-on experience with Veeva RIMS, preferably including implementation, key user activities or user training.
• Strong experience with preparation, validation and submission of eCTD dossiers globally, preferably using Veeva Submission Publishing.
• Experience with regulatory publishing, submission management and document processes.

Responsibilities

• Supporting global regulatory operations, including submission planning, document handling and regulatory follow-up
• Contributing to Veeva RIMS implementation, maintenance, user support and continuous improvement
• Preparing, compiling, technically validating and submitting regulatory dossiers in eCTD format across global markets
• Ensuring submission readiness, document quality and high-quality regulatory data
• Supporting product roll-out and life‑cycle management of marketing authorisations worldwide
• Collaborating with international affiliates and partners to prepare, compile and deliver regulatory documentation packages, ensuring timely submission and follow‑up of variation and other life‑cycle activities

Skills

Regulatory affairs

eCTD submissions

Veeva RIMS

Documentation handling

Education

Bachelor's degree in life sciences

Tools

Veeva RIMS

Job description

Pharmacosmos is seeking an experienced Regulatory Affairs Coordinator to join our Regulatory Affairs department. The role supports global regulatory operations, including eCTD submissions, regulatory publishing, and lifecycle activities across international markets.

The successful candidate will have hands-on experience with Veeva RIMS, expertise in preparing and submitting eCTD dossiers, and a proactive approach to data quality and process improvement.