Regulatory Affairs Lead

Regulatory Affairs Lead

**Category**:Reg Affairs & Safety Pharmacovigilance

**Location**:Singapore, Singapore, SG
- Headquartered in Singapore, we are re-establishing Region APAC with the clear ambition to triple patient reach and deliver on the potential of our 16 markets: 5 elevated affiliates with Oceania, India, Korea, Thailand, Indonesia, as well as with Business Area ‘BASEA’ responsible for these 11 countries: Bangladesh, Brunei, Cambodia, Laos, Malaysia, Maldives, Myanmar, Philippines, Singapore, Sri Lanka and Vietnam.
Our 3500 colleagues in APAC will pursue the opportunity to bring our innovative treatments to even more patients and contribute to IO’s ambition to Improve Health at Scale.

**About the department**
The newly created, focused function of Clinical and Regulatory has been established to reflect our significant clinical footprint and our vital role in supporting the company’s pipeline.
This strategic move underscores our commitment to advancing clinical development and ensuring regulatory compliance, which are essential to our success and growth. With a focus on clinical and regulatory excellence, we aim to further accelerate the introduction of our innovative treatments to patients in the region

**The position**
As a Regulatory Affairs Lead, you will develop regulatory strategies in APAC, support affiliates and represent the region in global settings. Travelling to the affiliates will be required.
- Develop regulatory strategies within the APAC region for the CVD portfolio, focusing on NDAs, major line extensions, and critical life cycle management (LCM) activities, ensuring that regulatory pathways, submissions, and approvals timelines align with the business prioritization.
- Drive optimal and timely product approvals and labeling claims by balancing local market perspectives with regional objectives and business goals.
- Provide strategic and tactical regulatory input to develop the portfolio LCM plan, enabling supply mitigation and/or optimization.
- Oversee communications and actions related to shortages or associated risks, including liaising with regulatory agencies within the APAC region.
- Represent APAC in Global Regulatory Portfolio Teams (GRPTs) and other relevant forums, supporting affiliates with escalations, risk management, and the pursuit of accelerated pathways.

**Qualifications**
- A university degree in a pharmaceutical, science-related field, or relevant business discipline. A postgraduate degree such as a PhD, MBA, or MSc is desirable.
- A minimum of 5-7 years of experience in R&D within the pharmaceutical industry or academia, combined with 5-7 years of regulatory affairs experience.
- Strong understanding of the pharmaceutical business, including expertise in regulatory evaluation skills such as evaluating regulatory options and risks.
- Experience in project management and strategic planning, with a focus on precision and flawless execution.
- Capable of working independently, excellent networking and communication skills, with the ability to build strong internal and external coalitions. Fluency in written and spoken English is required.

**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 chronic disease.

**Contact**

**Deadline**
3 January 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.
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