Manager, Regulatory Dossier Management

Job summary

The role involves leading a team in Regulatory Dossier Management, focusing on global regulatory activities from early development to marketing authorization and life-cycle management. The manager will coach team members, coordinate resources, and ensure the prioritization of regulatory activities.

Qualifications

• University degree in a relevant life science or medical discipline.
• At least 10 years of experience in Regulatory Affairs within the pharmaceutical industry.
• Solid understanding of pharmaceutical regulations and global regulatory environment.
• Ability to prioritize and coordinate multiple activities while building strong relationships across functions.
• Previous people management experience is advantageous but not required.

Responsibilities

• Lead and develop a team of regulatory professionals.
• Assign and coordinate resources for Regulatory Dossier Management activities.
• Ensure the development of competencies through Individual Development Plans.
• Coordinate and lead the execution of global regulatory strategies for drug projects.
• Foster collaboration and communication with key functional areas.

Skills

• Strong regulatory expertise.
• People-focused leadership with a passion for coaching and development.
• Excellent prioritization and coordination skills.

Education

• University degree in a relevant life science or medical discipline.

Tools

• Familiarity with regulatory management tools and systems is beneficial.