Associate Regulatory Affairs Specialist

Associate Regulatory Specialist

   

Company: Novo Nordisk Global Business Services (GBS)

Shape regulatory strategies that bring life-changing diabetes therapies to patients in every corner of the world. As an Associate Regulatory Specialist, you'll be the link between science, health authorities and the millions of people who depend on our medicines – with the autonomy to set direction, the expertise to influence outcomes, and the support of a global team behind you.

Your new role

As an Associate Regulatory Specialist in RA Diabetes, you will take ownership of regulatory submissions and interactions across major markets, acting as a subject matter expert within one or several regulatory processes. You'll work independently on most situations while shaping better practice for the team, mentoring junior colleagues and driving the regulatory strategy that supports our diabetes portfolio.

Day-to-day, your responsibilities will span:

• Global regulatory submissions: Develop and execute Regulatory Affairs Submission Plans in Vault RIM, prepare and publish regulatory files, and manage MAA/NDA/BLA, CTA/IND, PIP/PSP submissions, renewals, post-approval changes, pharmacovigilance documents (DSUR, PSUR, RMP), and meeting packages worldwide
• Health Authority interactions: Plan and conduct engagements with FDA, EMA, PMDA and other authorities – including preparing meeting requests, leading rehearsals and capturing minutes of formal meetings
• Core labelling: Establish and maintain the target CCDS/CCDS and European labelling for products in development, link the Target Product Profile to commercial and market access requirements, and support US labelling and Life Cycle Management
• RA Process expertise: Identify and develop better practice, driving improvements in regulatory documentation, methods and strategies
• RA Due Diligence: Lead regulatory due diligence assessments to inform business decisions
• RA Clinical expertise: Chair or contribute to Clinical Project / Clinical cross-functional groups, applying your submission experience across China, Japan, US and EU

Your new department

In Research & Development, you'll be part of a unit that explores bold scientific ideas and advances them into clinical testing. We combine curiosity, AI tools, and human data to develop transformative therapies. Through collaboration and operational excellence, we shape and deliver an innovative pipeline to meet future patient needs.

You will join RA Diabetes in Global Regulatory Affairs Bangalore, reporting to the Associate Director, RA Diabetes. The department works globally with Clinical Operations, Medical & Science, Global Safety, Global Medical Affairs, Global Marketing/Patient Access, Legal, Quality, RA affiliates and health authorities to support product development, approvals and lifecycle management. Together, we focus on high-quality regulatory submissions, continuous process improvement and collaborative cross-functional engagement to bring safe and effective therapies to patients worldwide.

Your skills & qualifications

We're looking for a confident regulatory professional who combines deep technical knowledge with a strategic mindset and the boldness to make risk-based decisions. To succeed in this role, you'll bring:

• A PhD, Master's or Bachelor's degree in life sciences, with 7–9+ years of relevant Regulatory Affairs experience – or equivalent knowledge gained through practical experience
• Strong expertise across several regulatory affairs disciplines such as regulatory science & requirements (EU, US, China, Japan), Life Cycle Management, label development, Health Authority interactions, device development, regulatory intelligence and therapeutic area knowledge
• Submission experience across major markets (China, Japan, US, EU) and a track record of identifying and implementing process improvements
• Broader understanding of project management, the R&D value chain, pharmacovigilance, clinical pharmacology, real world evidence, digital health and patient access
• Excellent written and spoken English, with strong cross-functional communication skills and the ability to operate effectively in a multicultural environment
• An open, accountable and inclusive mindset – goal-oriented, organised, persistent, and able to handle ambiguity, variable workloads and complex information with empathy and a collaborative spirit

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 stepping into a defining moment in our history, where your regulatory expertise directly shapes how millions of people living with diabetes access the therapies they need.

What we offer

There is, of course, more on offer here than the uniqueness of our culture and the extraordinary results we produce. 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.

Deadline

18 June 2026. Applications are reviewed on an ongoing basis, so please apply as soon as possible.

 

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.

Experience Level

Mid Level