Senior Regulatory Professional

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

• Develop regulatory strategies and lead their execution for Novo Nordisk's weight management portfolio in clinical development
• Participate in cross-functional project teams, including study groups and submission teams
• Interact with stakeholders from different departments
• Contribute to regulatory documentation for submission to Health Authorities, including briefing packages, clinical trial applications, clinical trial protocols and reports, and regulatory files for marketing authorisation
• Provide regulatory input and contribute to project team decisions shaping the portfolio
• Interact with medical and non-clinical specialists, statisticians and medical writers
• Report to the head of the department
• Participate in department-related activities and improvement projects across Regulatory Affairs

Requirements

• A Master's degree or Ph.D. in science, pharmaceutical or health science
• Minimum 5 years of experience in the pharmaceutical industry
• Solid, hands-on regulatory experience focusing on drug development and lifecycle activities
• Strong project management skills
• Experience in marketing authorisations is highly attractive
• Excellent communication skills
• Ability to cooperate at any organisational level
• Fluency in English, both written and spoken
• Can-do attitude and willingness to experiment
• Positive, self-motivated mindset
• Drive to challenge, contribute and take initiative in a complex cross-functional environment

Core Competencies

Demonstrates expertise in regulatory strategy development and execution within the pharmaceutical industry, with a strong focus on drug development and lifecycle activities. Proven ability to collaborate across functions and contribute to regulatory documentation for health authority submissions.

Highest-signal resume keywords

• Regulatory Strategy Development
• Drug Development Experience
• Project Management Skills
• Regulatory Documentation
• Marketing Authorisation Experience

Hard Skills

• Regulatory Strategy
• Drug Development
• Regulatory Documentation
• Clinical Trial Applications
• Clinical Trial Protocols
• Regulatory Files
• Project Management

Soft Skills

• Excellent Communication Skills
• Cooperation Across Organisational Levels
• Positive Mindset
• Self-Motivated
• Can-Do Attitude

Certifications & Qualifications

• Master's Degree
• Ph.D. in Science

Industry Keywords

• Pharmaceutical Industry
• Regulatory Affairs
• Health Authorities
• Weight Management Portfolio
• Cross-Functional Teams