Global Regulatory Submission Manager (Pharmaceutical, Kastrup)

Job summary

In this temporary role, you will oversee the entire lifecycle of global regulatory submissions, from planning to publishing, within a dynamic pharmaceutical environment.

Qualifications

• Hands-on experience with publishing systems, preferably Lorenz, and document management systems, preferably Veeva.
• Knowledge of eCTD requirements and electronic submission processes is highly desirable.
• Proven experience in Regulatory Affairs with a solid understanding of end-to-end regulatory filing processes.
• Excellent written and verbal communication skills to convey complex information clearly to diverse stakeholders.
• A relevant master’s degree or equivalent work experience.

Responsibilities

• Manage the preparation, submission, publishing, and lifecycle management of eCTD and other regulatory format dossiers.
• Maintain regulatory documentation and global applications, including variations and work-sharing procedures.
• Collaborate with cross-functional teams to ensure high-quality and timely submissions.
• Provide guidance on eCTD/non-eCTD requirements and contribute to the continuous optimization of submission processes.
• Prioritize and coordinate multiple projects, proactively addressing submission-related challenges.
• Train global colleagues in regulatory processes, systems, and tools.

Skills

• Technical flair and understanding of IT systems.
• Ability to bring structure and clarity to tasks, even under tight deadlines.

Education

• Relevant master’s degree or equivalent work experience.

Tools

• Familiarity with publishing systems (Lorenz) and document management systems (Veeva).