Are you ready to shape regulatory strategies that bring life-changing medicines to the patients who need them most? Join a team where your expertise in regulatory affairs and pharmacovigilance directly safeguards our licence to operate – and protects the safety of millions of people living with serious chronic diseases. Your new role As a Regulatory Affairs & Pharmacovigilance (RAPV) Associate, you will play a pivotal role in ensuring regulatory compliance and driving pharmacovigilance activities across our portfolio. You will monitor the regulatory environment, coordinate submissions and provide expert insight to stakeholders shaping the future of our products in the market. Day-to-day your tasks will include: <ul style="margin-top:0.0cm;margin-bottom:0.0cm" type="disc"> <li style="color:black;margin-bottom:0.0cm;text-align:justify;line-height:normal;margin-top:0.0cm;margin-right:0.0cm;font-size:11.0pt;font-family:Aptos, sans-serif">Regulatory compliance & monitoring: Ensuring adherence to relevant legislation and internal SOPs, updating local regulatory procedures, and maintaining close interactions with Health Authorities to manage approvals and detect emerging trends</li> <li style="color:black;margin-bottom:0.0cm;text-align:justify;line-height:normal;margin-top:0.0cm;margin-right:0.0cm;font-size:11.0pt;font-family:Aptos, sans-serif">Regulatory affairs coordination: Overseeing the assessment and submission of registration files, handling Health Authority requests for information, managing labelling variations and NDA submissions, and maintaining necessary licences</li> <li style="color:black;margin-bottom:0.0cm;text-align:justify;line-height:normal;margin-top:0.0cm;margin-right:0.0cm;font-size:11.0pt;font-family:Aptos, sans-serif">Regulatory support & insight: Contributing to Novo Nordisk's position on local regulatory proposals, sharing regulatory intelligence across the organisation, and ensuring audit readiness</li> <li style="color:black;margin-bottom:0.0cm;text-align:justify;line-height:normal;margin-top:0.0cm;margin-right:0.0cm;font-size:11.0pt;font-family:Aptos, sans-serif">Labelling & promotional material: Developing, reviewing and updating labelling and promotional content to ensure compliance with local regulations and Health Authority requirements</li> <li style="color:black;margin-bottom:0.0cm;text-align:justify;line-height:normal;margin-top:0.0cm;margin-right:0.0cm;font-size:11.0pt;font-family:Aptos, sans-serif">Pharmacovigilance support: Delivering internal PV training, managing safety reporting, performing compliance checks, and supporting the update and maintenance of PV systems and processes</li> </ul> Your new department You will join our Regulatory Affairs and Pharmacovigilance team under the Medical & Regulatory (MR) department. We are dedicated to securing regulatory compliance for new products and product amendments – protecting our licence to operate and, most importantly, patient safety. Working closely with Health Authorities and policymakers, we help shape the regulatory frameworks of tomorrow in a collaborative and dynamic environment where your work has real impact on patients worldwide. Your skills & qualifications We are looking for a collaborative professional who thrives at the intersection of science, regulation and stakeholder management. To succeed in this role, you will bring: <ul style="margin-top:0.0cm;margin-bottom:0.0cm" type="disc"> <li style="color:black;margin-bottom:0.0cm;text-align:justify;line-height:normal;margin-top:0.0cm;margin-right:0.0cm;font-size:11.0pt;font-family:Aptos, sans-serif">A Bachelor's degree in Life Sciences, Pharmacy or a related field</li> <li style="color:black;margin-bottom:0.0cm;text-align:justify;line-height:normal;margin-top:0.0cm;margin-right:0.0cm;font-size:11.0pt;font-family:Aptos, sans-serif">Proven experience in regulatory affairs and pharmacovigilance within the pharmaceutical industry</li> <li style="color:black;margin-bottom:0.0cm;text-align:justify;line-height:normal;margin-top:0.0cm;margin-right:0.0cm;font-size:11.0pt;font-family:Aptos, sans-serif">Strong understanding of regulatory requirements, compliance standards and Health Authority interactions</li> <li style="color:black;margin-bottom:0.0cm;text-align:justify;line-height:normal;margin-top:0.0cm;margin-right:0.0cm;font-size:11.0pt;font-family:Aptos, sans-serif">Hands-on experience with regulatory submissions, labelling variations and managing licensing activities</li> <li style="color:black;margin-bottom:0.0cm;text-align:justify;line-height:normal;margin-top:0.0cm;margin-right:0.0cm;font-size:11.0pt;font-family:Aptos, sans-serif">Excellent communication and interpersonal skills, with the ability to work collaboratively with internal teams and external stakeholders</li> </ul> Working at Novo Nordisk Every day we seek the solutions that defeat serious chronic diseases. To do this, we approach our work with determination, constant curiosity and a commitment to finding better ways forward. For over 100 years, this dedication has driven us to build a company focused on lasting change for long-term health. One where diverse thinking, shared purpose and mutual respect come together to create extraordinary results. When you join us, you're not just starting a job – you're becoming part of a story that spans generations. Deadline 20 Jul 2026 We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and preventing diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

Regulatory Affairs & Phamacovigilance Associate (Kuala Lumpur, Kuala Lumpur, MY) @ novonord

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