Regulatory Affairs Director
8 hours ago
**About the department**
You will join our Regulatory Affairs team in Region APAC, based in Singapore. Our team is responsible for ensuring regulatory compliance for new products and product amendments, thereby keeping our license to operate. We work closely with health authorities and policymakers to shape future regulatory frameworks and ensure the safety of our medicines. The atmosphere in our department is dynamic and collaborative, with a strong focus on capability building and development.
**The position**
In this role you, you will be responsible for ensuring the Region APAC regulatory strategic direction enables the regional commercial success, by obtaining timely regulatory approvals with optimal product claims and facilitating optimal launch conditions for new products and life cycle improvements across the region.
Among your main responsibilities will be:
- Developing and driving the strategic direction for the Regulatory Affairs function in Region APAC to ensure alignment with business needs and timely regulatory approvals. Offering strategic regulatory expertise to key counterparts to ensure commercial success aligned with corporate strategies and priorities.
- Ensuring that the Region APAC strategy, priorities, and regulatory needs are reflected in global Regulatory Affairs and International Operations strategies. Providing regulatory expertise, leadership, and consultation to identify and address regional business opportunities from a Regulatory Affairs perspective.
- Maximizing the synergies of the regulatory function within Region APAC Clinical & Regulatory function and strengthen RA partnerships with key stakeholders.
- Engaging in capability building and further development of regulatory staff across Region APAC to enhance efficiency and competencies.
- Leading regulatory policy and advocacy activities across Region APAC and represent NN towards external stakeholders and fora.
**Qualifications**
- University degree (Pharmaceutical, medical/life science related field or relevant business orientation); a relevant Post Graduate degree (e.g. PhD, MBA, or MSc) would be a plus.
- 7-10 years of relevant international experience in the Pharmaceutical Industry in a Regulatory role.
- People management experience with both strategic and operational leadership responsibilities.
- Strong communication skills and profound stakeholder management capabilities.
- Robust enterprise mindset with a focus on setting strategic direction and proactive planning.
**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 energise 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.
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