Regulatory Affairs Specialist

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

Job summary

Novo Nordisk seeks a senior Regulatory Affairs professional to lead global marketing authorisation submissions for obesity and cardiometabolic projects, shaping strategy across development and lifecycle management.

You will guide a submission team, collaborate with cross-functional stakeholders, and drive innovative filing structures to speed and ensure quality regulatory decisions.

Qualifications

• Master's or PhD in Life Science, Pharmaceutical, or Health Science.
• 7–8 years of Regulatory Affairs experience with solid hands-on global MA submissions.
• Experience with regulatory strategy across development projects and lifecycle management.
• Strong negotiation skills and understanding of the pharmaceutical value chain.
• Excellent communication skills across organizational levels.
• Fluency in written and spoken English.

Responsibilities

• Contribute to the late-stage development strategy for obesity and cardiometabolic assets.
• Develop and plan the global marketing authorisation submission strategy for complex programmes.
• Drive innovative submission strategies to support complexity, speed, and quality.
• Lead the regulatory submission team and cross-functional stakeholders for timely delivery.
• Work across development projects in lifecycle management to ensure coherent regulatory strategy.

Skills

Regulatory Affairs

Global submissions

Cross-functional

Regulatory strategy

Negotiation

English fluency

Education

Master's degree in Life Science

Ph.D. degree

Job description

• Contributing to the late-stage development strategy for one of Novo Nordisk's key assets within the obesity and cardiometabolic health therapy area


• Developing and planning the global marketing authorisation submission strategy for a highly complex development programme pursuing multiple indications


• Driving innovative and fit-for-purpose submission strategies, including exploring new ways of structuring and executing submissions to support complexity, speed, and quality


• Leading and guiding the regulatory submission team and cross-functional stakeholders to ensure aligned execution, strong decision-making, and timely delivery of submission activities


• Working across development projects in combination with life cycle management activities, ensuring a coherent and forward-looking regulatory strategy

Requirements

• A Master's or Ph.D. degree in Life Science, Pharmaceutical or Health Science


• Minimum 7–8 years of experience in Regulatory Affairs with solid, hands-on experience in global marketing authorisation applications


• Proven experience working with regulatory strategy across development projects and life cycle management


• Strong negotiation skills and a sound understanding of the pharmaceutical value chain


• Excellent communication skills with the ability to cooperate at any organisational level


• Fluency in written and spoken English.

Core Competencies

Demonstrates expertise in Regulatory Affairs with a focus on global marketing authorisation submissions and regulatory strategy across development projects. Proven ability to lead cross-functional teams and drive innovative submission strategies in the pharmaceutical industry.

Highest-signal resume keywords

• Regulatory Affairs Experience


• Global Marketing Authorisation Applications


• Regulatory Strategy Development


• Negotiation Skills


• Life Cycle Management

Hard Skills

• Regulatory Submission Strategy


• Complex Development Programme Management


• Submission Execution


• Pharmaceutical Value Chain Understanding


• Life Science Knowledge

Soft Skills

• Excellent Communication Skills


• Strong Decision-Making


• Team Leadership


• Collaboration

Certifications & Qualifications

• Master's Degree


• Ph.D. Degree

Industry Keywords

• Obesity Therapy


• Cardiometabolic Health


• Regulatory Submission Team


• Cross-Functional Stakeholders


• Development Projects