Regulatory Strategy Lead, Weight Management Portfolio

Jobtailor; Søborg; On-site; DKK 900,000 - 1,300,000; Full time

Job summary

Novo Nordisk in Denmark is seeking a senior Regulatory Affairs professional to develop regulatory strategies and lead their execution for a weight management portfolio in clinical development. You will participate in cross-functional project teams, interact with stakeholders from different departments, and contribute to regulatory documentation for health authority submissions.

The role reports to the head of the department and involves driving lifecycle activities, coordinating study groups and

Qualifications

• Master's or Ph.D. in science, pharmaceutical or health science.
• Minimum 5 years in the pharmaceutical industry.
• Regulatory experience focusing on drug development and lifecycle activities.
• Strong project management skills.
• Experience in marketing authorisations is highly attractive.
• Excellent communication and ability to cooperate at all levels.
• Fluency in English, both written and spoken.

Responsibilities

• Develop regulatory strategies and lead their execution for the portfolio.
• Participate in cross-functional project teams and study groups.
• Interact with stakeholders from different departments.
• Contribute to regulatory documentation for health authority submissions.
• Provide regulatory input to project team decisions.
• Interact with medical and non-clinical specialists and writers.
• Report to the head of the department.
• Participate in department activities and improvement projects.

Skills

Regulatory Strategy

Drug Development

Project Management

Regulatory Documentation

Marketing Authorisation Experience

Communication

Cross-functional Collaboration

Education

Master's Degree

Ph.D. in Science

Job description

Novo Nordisk in Denmark is seeking a senior Regulatory Affairs professional to develop regulatory strategies and lead their execution for a weight management portfolio in clinical development. You will participate in cross-functional project teams, interact with stakeholders from different departments, and contribute to regulatory documentation for health authority submissions.

The role reports to the head of the department and involves driving lifecycle activities, coordinating study groups and