Medical and Regulatory Affairs Head

Medical and Regulatory Affairs Head

**Category**:Medical Affairs

**Location**:Singapore, Singapore, SG

**About the 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.

**The position**
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. Additionally, you will be responsible for 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. You are also responsible for ensuring new business opportunities are considered aligned to the strategic objectives of the affiliate.
Other role expectations are as follows but is not limited to:

- Medical Affairs - Ensure 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.
- Regulatory Affairs - Oversee the execution of regulatory strategies and activities, including New Drug Applications, product label updates, and compliance with Singapore Health Sciences Authority 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.
- Pharmacovigilance - the role involves ensuring timely training on safety updates for NN products, approving adverse event reports for submission to HSA, overseeing pharmacovigilance activities, and accurately reporting and following up on adverse drug reactions, adverse events, technical complaints, and troubleshooting within required timelines.

**Qualifications**
- 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**
We are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities, and challenges. For employees at Novo Nordisk, life means many things - from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energize us to perform our best at work. Ultimately, life is why we’re all here - to ensure that people can lead a life independent of chron-ic disease.

**Contact**

**Deadline**
4 February 2025
- We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
- At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
- #LI-AMS1