Senior Regulatory Affairs Professional

Senior Regulatory Professional

   

Department : Regulatory Affairs
Location   : Novo Nordisk Global Business Services (GBS) India Bangalore
Job Level  : 7

Shape regulatory strategies that bring life-changing therapies to patients with Obesity & Cardiometabolic Health worldwide.

Your new role
As a Senior Regulatory Professional, you'll be the regulatory voice driving submissions and label development for Obesity & Cardiometabolic Health therapies across global markets including the EU, US, China and Japan. You'll operate with significant independence, applying your regulatory expertise to solve complex challenges while shaping strategies that directly impact patients' access to treatment.

 

Your responsibilities will include:

• Leading end-to-end regulatory submissions to health authorities worldwide, from strategic planning through to approval and lifecycle management, including MAA/NDA/BLA, CTA/IND, and post-approval changes
• Planning and conducting regulatory interactions with health authorities, including preparation of meeting requests, packages, and formal meeting participation
• Developing and maintaining core labelling (target CCDS/CCDS, European labelling) that links business opportunities and key differentiators to regulatory and market access requirements
• Serving as a Regulatory Affairs process expert, identifying better practices and driving improvements in regulatory documentation, methods and strategies
• Leading regulatory due diligence activities and providing clinical expertise as chair or member of cross-functional expert groups
  Mentoring junior colleagues and contributing to the continuous development of regulatory capabilities within the team

 

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 the RA RED , Obesity & Cardiometabolic Health team within Global Regulatory Affairs Bangalore, reporting to the Associate Director, RA RED Obesity & Cardiometabolic Health. Our department collaborates globally with Clinical Operations, Medical & Science, Global Safety, Global Medical Affairs, Global Marketing/Patient Access, Legal, Quality, RA affiliates and health authorities (FDA, EMA, PMDA and others). We focus on delivering high-quality regulatory submissions, continuously improving our processes, and engaging cross-functionally to bring safe and effective therapies to patients within Obesity & Cardiometabolic Health worldwide.

 

Skills & qualifications

We're looking for a Senior Regulatory Professional who thrives in a complex, global regulatory environment and brings strategic thinking to every submission. You'll bring with you:

• PhD, Master's or Bachelor's degree in life sciences with 9+ years of relevant regulatory affairs experience
• 7-9 years of work experience demonstrating solid regulatory affairs qualifiers including regulatory science & requirements (EU, US, China, Japan), lifecycle management, label development, and health authority interactions
• Proven track record with China, Japan, US and EU submission experience, with expertise in managing regulatory submissions from planning through approval
• Strong knowledge of regulatory therapeutic areas, device development, and regulatory intelligence, combined with cross-functional understanding across the R&D value chain
• Demonstrated ability to work independently with high initiative, make complex decisions involving multiple stakeholders, and identify better practices that improve regulatory processes
• Experience mentoring colleagues and contributing to team development
• Fluent written and spoken English

 

Working at Novo Nordisk
For over 100 years, we've been driven by a dedication to defeat serious chronic diseases including diabetes , Obesity and rare endocrine disorders. This means your regulatory expertise doesn't just navigate compliance—it opens pathways for patients to access treatments that can transform their lives. Here, you'll work alongside curious, committed colleagues who value your perspective and expertise. Our culture of warmth and mutual respect creates an environment where collaboration thrives across functions and geographies. As we continue our remarkable transformation journey, ex-panding into new therapeutic areas, you'll find opportunities to grow your regulatory career in directions you might not have imagined. This is regulatory affairs with purpose—where your strategic decisions create lasting change for long-term health.

 

Deadline
21 April 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.

Experience Level

Senior Level