Medical & Regulatory Affairs Head

Medical & Regulatory Affairs Head
Medical & Regulatory Affairs
Singapore

Are you passionate about medical affairs and regulatory strategies? Do you have a knack for ensuring compliance and driving scientific communication? If so, you might be the perfect fit for our Medical and Regulatory Head position! Read more and apply today.

Your new role
As the Medical and Regulatory Head, you will include developing and executing strategies in these areas:

• Acting as the local point of contact for regional counterparts and ensuring continuous capability-building of the medical function.
• Contributing to core development programs through, ensuring high-quality and timely execution of medical activities, overseeing regulatory strategy and activities, and ensuring compliance with drug safety standards. 
• Ensuring new business opportunities are considered aligned to the strategic objectives of the affiliate. 
• Ensuring the accuracy of medical and scientific information in publications, symposiums, and promotional materials, overseeing the execution of key medical activities such as clinical trials, medical events, and scientific publications, providing training on compounds, building and developing the Medical Affairs team, and ensuring a functioning medical information system.
• Oversee the execution of regulatory strategies and activities, including New Drug Applications, product label updates, and compliance with Singapore Food and Drug Administration (FDA) guidelines, monitoring the regulatory environment, ensuring timely submissions for all therapeutic areas, supporting the continuous marketability of products, and ensuring compliance with drug safety standards.
• Ensuring timely training on safety updates for Novo Nordisk products, approving adverse event reports for submission to Health Sciences Authority (HSA), overseeing pharmacovigilance activities, and accurately reporting and following up on adverse drug reactions, adverse events, technical complaints, and troubleshooting within required timelines.

Your new department
In Novo Nordisk, the Medical and Regulatory Affairs secure the approval of new multibillion-dollar products and drug indications, making it possible for the company to bring innovative products to patients. We stand at the centre of project planning and execution from the earliest stages of drug development all the way through life-cycle management, meaning that we are involved across the entire drug value chain from early research to commercialisation and beyond.
This is a great opportunity to collaborate with colleagues and stakeholders across the globe, gaining a good understanding of the Novo Nordisk organisation, the value chain and key regulatory stakeholders and built on key transferable skills within communication, navigating data as well as project-and stakeholder management. The role will be reporting to the General Manager and will oversee Singapore and Brunei.

Your skills and qualifications
We’re looking for a Medical & Regulatory Affairs Head who will enjoy working in a high-paced, dynamic environment. You’ll bring with you:

• Must be a licensed physician or must have biomedical sciences degree. Post graduate qualification desirable.
• Minimum 5 years of industry experience in medical affairs function, ideally in related therapeutic areas, and must have at least 2 years in the managerial role.
• Experience in defined therapy areas (desirable) i.e. Diabetes, Obesity, CV, other Endocrine related disorders, Haemophilia).
• Understanding of Singapore health care structure and regulatory environment will be a significant advantage.
• Excellent verbal and written communication skills.

Working at Novo Nordisk
Every day we seek the solutions that defeat serious chronic diseases. To do this, we approach our work with an unconventional spirit, a rare determination and a constant curiosity. For over 100 years this unordinary mindset has seen us build a company unlike any other. One where a collective passion for our purpose, mutual respect and a willingness to go beyond what we know delivers extraordinary results.
 
Deadline
18 November 2025. Applications are reviewed on an ongoing basis. 

Novo Nordisk is currently in the process of adjusting job titles globally. Please note that the job title listed in this advertisement may be subject to change. More detailed information will be provided during the recruitment process.

Novo Nordisk is not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health.

#LI-AMS1