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 be responsible for developing and executing strategies in these areas: Act as the local point of contact for regional counterparts and ensure continuous capability-building of the medical function. Contribute to core development programs, ensuring high‑quality and timely execution of medical activities, overseeing regulatory strategy and activities, and ensuring compliance with drug safety standards. Ensure new business opportunities are considered aligned to the strategic objectives of the affiliate. Ensure the accuracy of medical and scientific information in publications, symposiums, and promotional materials, oversee the execution of key medical activities such as clinical trials, medical events, and scientific publications, provide training on compounds, build and develop the Medical Affairs team, and ensure 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, monitor the regulatory environment, ensure timely submissions for all therapeutic areas, support the continuous marketability of products, and ensure compliance with drug safety standards. Ensure timely training on safety updates for Novo Nordisk products, approve adverse event reports for submission to Health Sciences Authority (HSA), oversee pharmacovigilance activities, and accurately report and follow 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, enabling the company to bring innovative products to patients. We are involved across the entire drug value chain from early research to commercialisation and beyond. This role will report to the General Manager and will oversee Singapore and Brunei. Your skills and qualifications Must be a licensed physician or hold a biomedical sciences degree; a postgraduate qualification is desirable. Minimum five years of industry experience in a medical affairs function, ideally in related therapeutic areas, and at least two years in a managerial role. Experience in defined therapy areas (desirable), e.g., Diabetes, Obesity, Cardiovascular, other endocrine disorders, Haemophilia. Understanding of Singapore's healthcare structure and regulatory environment will be a significant advantage. Excellent verbal and written communication skills. Working at Novo Nordisk Every day we seek solutions that defeat serious chronic diseases. We approach our work with an unconventional spirit, determination, and constant curiosity. For over 100 years, this mindset has built a company unlike any other, where collective passion, mutual respect, and a willingness to go beyond what we know drive extraordinary results. Deadline 18 November 2025. Applications are reviewed on an ongoing basis. Note: Novo Nordisk is currently adjusting job titles globally. The job title listed may be subject to change. More detailed information will be provided during the recruitment process. #J-18808-Ljbffr