Regulatory Professional I Region Emerging Markets
Job Summary
Job Title: Regulatory Professional I Region Emerging markets
Department: IORA Bangalore
Location: Bangalore India
Company: NovoNordisk GBS India
Be the regulatory expert who ensures life-saving medicines reach patients across the this role youll 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 Regulatory Professional II youll serve as a subject matter expert supporting country-specific regulatory submissions and approvals for specific markets in Region Europe and Canada.
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.
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 functions 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
Were looking for an experienced regulatory professional who thrives in a dynamic cross-cultural environment and can balance technical expertise with strong relationship management. Youll bring:
- Postgraduate degree in science or related field with 6 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.
- Highly proactive and able to take initiatives. Self-managed strong personal drive and ability to engage with colleagues and peers towards delivering excellent performance and results.
- 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 youll 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 youre not just starting a job youre becoming part of a story that spans generations.
What we offer
Being part of a global healthcare company means opportunities to learn and develop are all around us. Youll work on high-impact projects that directly affect patient access to medicines while building expertise across regulatory systems regions and therapeutic areas. Our benefits are designed with your career and life stage in mind supporting you to thrive both professionally and personally.
Deadline: 04 June 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 were not chasing quick fixes were creating lasting change for long-term health. For over 100 years weve 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 whats possible in healthcare. We embrace diverse perspectives seek out bold ideas and build partnerships rooted in shared purpose. Together were 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.
Required Experience:
Unclear Seniority
About Company
Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases.