Regulatory Affairs Lead - Cardiovascular Outcome Trials

at  Novo Nordisk

Regulatory Affairs Lead - Cardiovascular Outcome Trials
Category: Reg Affairs & Safety Pharmacovigilance
Location:Søborg, Capital Region of Denmark, DK
Dive into the dynamic world of Regulatory Affairs at Novo Nordisk. Our team is devoted to gaining global approvals for our innovative medicines. With a deep scientific understanding, a patient focus, and expertise in managing diverse stakeholder interests, every day with us is rewarding and intellectually enriching.
We are currently looking for Regulatory Affairs (RA) Specialist with a strong scientific background and a genuine interest in contributing to future developments within cardiometabolic and renal disease. Apply now for this life-changing opportunity!

QUALIFICATIONS

To succeed in this role, we expect you to have:

• An academic degree such as master’s degree and/or a Ph.D. within Life Science, Health Science or a related field coupled with a substantial and proven track record of relevant working experience
• Solid practice with handling regulatory documentation for pharmaceutical development within the quality, non-clinical or clinical areas
• Experience interacting directly with major health authorities on a global level (including FDA, EMA, PMDA, NMPA)
• Strong negotiation skills and a sound understanding of business and data
• Experience working within the diabetes or obesity areas is an advantage
• Fluent written and spoken English

As a person, you are well-organised and have solid problem-solving capabilities, just as you show a winning attitude and never lose your strategic focus. You can keep your spirits high even when under pressure. Your adept communication skills span across all levels of an organization.
You are proficient in providing guidance, leadership, and motivation, you adeptly steer your team towards shared objectives. Simultaneously, you actively contribute as a collaborative team member, readily assisting your colleagues.

Your key responsibilities will include:

• Collaborating closely with the Global Regulatory Lead to facilitate worldwide submissions and ensure successful approval, with a particular focus on type II variation submissions, Q&As, roll-out activities
• Driving cross-functional teams to develop strategies and address inquiries from major Health Authorities, driving regulatory approval progress
• Actively contributing to strategic project discussions, shaping regulatory strategies, challenging assumptions, and influencing critical business decisions.
• Contributing to initiatives aimed at optimising regulatory processes across the organization
• Mentoring junior colleagues by sharing your expertise to support their professional developmen

To succeed in this role, we expect you to have:

• An academic degree such as master’s degree and/or a Ph.D. within Life Science, Health Science or a related field coupled with a substantial and proven track record of relevant working experience
• Solid practice with handling regulatory documentation for pharmaceutical development within the quality, non-clinical or clinical areas
• Experience interacting directly with major health authorities on a global level (including FDA, EMA, PMDA, NMPA)
• Strong negotiation skills and a sound understanding of business and data
• Experience working within the diabetes or obesity areas is an advantage
• Fluent written and spoken Englis