Senior Regulatory Professional- Region Emerging Markets

Category:  Reg Affairs & Safety Pharmacovigilance
Location: 

Bangalore, Karnataka, IN

   

Job Title: Senior Regulatory Professional – Region Emerging Markets
Department: IORA Bangalore
Location: Bangalore, India

Company: Novo Nordisk Global Business Services (GBS) India

 

 

Be the regulatory expert who ensures life-saving medicines reach patients across the globe. In this role, you'll combine deep technical knowledge with strategic stakeholder management to drive approvals in multiple countries while mentoring the next generation of regulatory professionals.

 

Your new role

As a Senior Regulatory Professional, you'll serve as a subject matter expert supporting country-specific regulatory submissions and approvals for specific markets in Region Emerging Markets.

Your responsibilities will include:

  • Leading the compilation, submission and approval of country-specific submission files for assigned countries (NDA, lifecycle management and post-approval changes).
  • Reviewing labelling and promotional materials, ensuring compliance with local regulatory agency requirements.
  • Monitor applications through distributers / health authority evaluation stages and coordinating responses to queries during the approval process.
  • Engage with distributers / authorities as relevant to ensure product approvals are secured and compliance as per local HA requirements are maintained.
  • Monitor the local regulatory environment and ensure overall regulatory compliance in collaboration with local RA.
  • Building and maintaining strong working relationships with global regulatory affairs teams, affiliates, distributors and local health authorities.
  • Driving continuous improvement initiatives and sharing best practices across the regulatory affairs network.

This position requires you to be highly self-motivated, proactive, organised and have excellent stakeholder management & communication skills. We are looking for candidates who have high ability to articulate regulatory signals and good understanding of country specific HA requirements.

 

Your new department
The International Operations Regulatory Affairs - Bangalore is a critical extension of the global IO-SO RA (Zurich & Copenhagen) Organisation. Together, we deliver on the function’s aspiration to enable fast growth, portfolio integration, and business continuity at scale. Our team consists of high caliber regulatory professionals offering core regulatory capabilities, enabling Novo Nordisk to secure fast, high-quality product approvals across International Operations.

 

Your skills & qualifications

We're looking for an experienced regulatory professional who thrives in a dynamic, cross-cultural environment and can balance technical expertise with strong relationship management. You'll bring:

  • Postgraduate degree in science, or related field with 8+ years of experience in regulatory affairs.
  • Excellent knowledge of pharmaceutical regulatory guidelines, country specific HA landscape and health authority requirements across multiple markets.
  • Strong understanding of E2E regulatory processes. Hands on experience on handling conversations with Health authority preferred.
  • Highly proactive and able to take initiatives & manage multiple priorities. Self-managed, strong personal drive and ability to engage with colleagues and peers towards delivering excellent performance and results.
  • Basic project management and strong commercial acumen
  • Cultural awareness and ability to collaborate effectively in a multicultural, global environment.

 

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. Here, you'll find a culture that values your expertise, provides opportunities to expand your skills across our transformation journey, and empowers you to make decisions that directly impact millions of patients' lives. When you join us, you're not just starting a job – you're becoming part of a story that spans generations.

 

Deadline:  06 May 2026. (Applications are reviewed on an ongoing basis).

 

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.