Job Description

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Regulatory Affairs and Pharmacovigilance Associate
Category: Reg Affairs & Safety Pharmacovigilance
Location:
Kuala Lumpur, Kuala Lumpur, MY
Regulatory Affairs and Pharmacovigilance Associate
Clinical, Medical and Regulatory Department
Kuala Lumpur, Malaysia
Are you passionate about regulatory affairs and pharmacovigilance? Novo Nordisk is on the lookout for a dedicated Regulatory Affairs (RA) and Pharmacovigilance (PV) Associate to join our team. This role is your chance to shape regulatory strategies, ensure compliance, and drive impactful changes in a leading global company. Be part of a forward-thinking company that values innovation and collaboration. Grow your career while making a real difference! Apply now!
Your new role
In this Kuala Lumpur-based role, you will play a pivotal part in ensuring regulatory compliance and supporting pharmacovigilance activities. You will also be responsible for monitoring regulatory environments, coordinating regulatory affairs applications, and providing regulatory assistance and insights to key stakeholders.
The main scope of accountabilities includes, but is not limited to:

• Regulatory Compliance & Monitoring: Ensure adherence to relevant legislation and internal Standard Operating Procedure(s) (SOPs), update local regulatory procedures, and maintain close interactions with Health Authorities to manage approvals and detect trends.
• Regulatory Affairs Coordination: Oversee the assessment and submission of registration files, handle Health Authorities' requests for information, manage labeling variations and NDA submissions, and maintain necessary licenses.
• Regulatory & Insight: Contribute to shaping Novo Nordisk's position on local regulatory proposals, share regulatory intelligence, and ensure audit readiness for regulatory affairs.
• Labelling & Promotional Material: Develop, review, and update labeling material and promotional content to ensure compliance with local regulations and Health Authority requirements.
• Pharmacovigilance (PV): Assist with internal PV training, manage safety data, perform compliance checks, and assist with the update and maintenance of PV systems and processes.

Your new department
The Regulatory Affairs and Pharmacovigilance team under the Clinical, Medical and Regulatory (CMR) Department. Our team is dedicated to ensuring regulatory compliance for new products and product amendments, thereby keeping our licence to operate. We work closely with Health Authorities and policymakers to shape future regulatory frameworks and safeguard patient safety. Our dynamic and collaborative environment allows us to make a significant impact on the lives of patients worldwide.
Your skills & qualifications
To be successful in this role, we are looking for a candidate who possesses these qualifications:

• Bachelor's degree in Life Sciences, Pharmacy, or a related field.
• Proven experience in regulatory affairs and pharmacovigilance.
• Strong comprehension of regulatory requirements and compliance.
• Excellent communication and interpersonal skills. Ability to work collaboratively with internal and external stakeholders.
• Experience with regulatory submissions and managing licensing activities.

Working at Novo Nordisk
Every day we seek the solutions that defeat serious chronic diseases. To do this, we approach our work with an unconventional spirit, a rare determination and a constant curiosity. For over 100 years this unordinary mindset has seen us build a company unlike any other. One where a collective passion for our purpose, mutual respect and a willingness to go beyond what we know delivers extraordinary results.
What we offer
Novo Nordisk's culture is characterized by a strong commitment to innovation, collaboration, and ethical responsibility, fostering an environment where employees are empowered to make a meaningful impact on patients' lives and global health. Being part of a global healthcare company means opportunities to learn and develop are all around us, while our benefits are designed with your career and life stage in mind.
More information
Please apply directly on the link and a Talent Acquisition Sourcer will contact you.
Deadline
7 October 2025. Applications are reviewed on an ongoing basis.
Novo Nordisk is not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health.

Skills Required