Global Regulatory Strategy Lead (Pharma)

Cari; Denmark; Remote; DKK 743,000 - 1,092,000; Full time

Job summary

Novo Nordisk is seeking a Regulatory Affairs Specialist to develop regulatory strategies and drive execution across global portfolios. You will collaborate with cross-functional teams and lead interactions with health authorities, shaping development plans and labeling strategies.

The role emphasizes leadership, strategic thinking, and strong communication across affiliates and global stakeholders, with a focus on delivering compliant, timely regulatory submissions in obesity and chronic health

Qualifications

• Master's degree or Ph.D. in science, pharmaceutical or health science
• Minimum 7-8 years of experience in Regulatory Affairs or other relevant area in drug development
• Practical knowledge in defining and developing global regulatory strategies and good all-around understanding of the regulatory documentation and requirements for pharmaceutical development and licensing
• Ability to communicate in fluent English (both written and spoken)
• Bring a can-do attitude and demonstrate a flexible, change-oriented approach
• Demonstrate proactivity and employ excellent project management skills
• Have a willingness to experiment and a tendency to view challenging situations as opportunities rather than limitations
• Are a skilled communicator who can cooperate at any organizational level
• Bring a positive attitude and are self-motivated

Responsibilities

• Contribute regulatory expertise to global development strategies by identifying opportunities, assessing risks, and providing strategic recommendations
• Leading key regulatory submission activities, including briefing packages for interactions with Health Authorities, clinical trial applications, and global regulatory submission initiatives ensuring high-quality and timely deliverables
• Collaborating with affiliates and international stakeholders to ensure alignment between local and global regulatory strategies and support successful implementation across markets
• Act as a trusted regulatory partner by coaching, sparring with, and guiding regulatory professionals, sharing knowledge and contributing to capability development within the organization
• Participating in departmental initiatives and continuous improvement projects that strengthen regulatory excellence and operational effectiveness

Skills

Regulatory strategy development

Communication skills

Project management

Cross-functional collaboration

Change management mindset

Education

Master's degree or Ph.D. in science, pharmaceutical or health science

Job description

Novo Nordisk is seeking a Regulatory Affairs Specialist to develop regulatory strategies and drive execution across global portfolios. You will collaborate with cross-functional teams and lead interactions with health authorities, shaping development plans and labeling strategies.

The role emphasizes leadership, strategic thinking, and strong communication across affiliates and global stakeholders, with a focus on delivering compliant, timely regulatory submissions in obesity and chronic health