Category: Regulatory Affairs & Pharmacovigilance
Location: Bangalore, Karnataka, India
Department: IORA Bangalore
Company: Novo Nordisk
Application Deadline: 06 May 2026
Experience Required: 8+ years (Not suitable for freshers)
About the Company
Novo Nordisk is a globally established healthcare leader with over a century of expertise in addressing serious chronic diseases. With a strong presence across international markets, the organization is known for its innovation-driven approach, regulatory excellence, and commitment to improving patient outcomes worldwide.
Job Overview
This Senior Regulatory Professional role is designed for experienced regulatory affairs specialists who can drive country-specific submissions and approvals across emerging markets. The position requires a combination of regulatory expertise, cross-functional collaboration, and strategic stakeholder management to ensure timely and compliant product approvals.
Key Responsibilities
Lead end-to-end regulatory submissions including NDA filings, lifecycle management, and post-approval variations for assigned markets
Compile, review, and submit high-quality regulatory dossiers aligned with country-specific health authority requirements
Ensure compliance of labeling and promotional materials with local regulatory frameworks
Track submission progress through distributors and health authority review stages, ensuring timely responses to queries
Liaise with distributors, affiliates, and health authorities to secure approvals and maintain compliance
Monitor evolving regulatory landscapes across emerging markets and implement necessary updates
Collaborate with global regulatory teams to align strategies and ensure seamless execution
Drive continuous improvement initiatives and share regulatory best practices across global teams
Required Qualifications
Postgraduate degree in Life Sciences, Pharmacy, or a related scientific discipline
Minimum 8+ years of experience in Regulatory Affairs within the pharmaceutical or biotech industry
Strong knowledge of global and country-specific regulatory guidelines and health authority expectations
Hands-on experience in regulatory submissions, approvals, and direct interaction with health authorities
Understanding of end-to-end regulatory processes across multiple markets
Excellent stakeholder management, communication, and cross-cultural collaboration skills
Strong analytical mindset with the ability to manage multiple priorities in a dynamic environment
Department Overview
The International Operations Regulatory Affairs team in Bangalore serves as a strategic extension of global regulatory operations. The team plays a pivotal role in enabling rapid product approvals, ensuring compliance, and supporting business continuity across international markets through high-quality regulatory execution.
Why Join This Role
Work on global regulatory submissions impacting multiple international markets
Be part of a high-impact regulatory function within a globally recognized healthcare organization
Collaborate with cross-functional and multicultural teams
Opportunity to contribute to regulatory strategy and decision-making at scale
Exposure to complex regulatory environments and emerging market dynamics
Important Note for Applicants
This is a senior-level regulatory affairs role requiring substantial industry experience. Freshers or entry-level candidates are advised to apply for junior regulatory roles such as Regulatory Affairs Associate or Pharmacovigilance Associate positions to build foundational experience before applying to senior roles.
How to Apply
Interested candidates can apply through the official careers page of Novo Nordisk or explore verified global opportunities on ThePharmaDaily.com.
Uttar Pradesh :
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Remote, India | Siliguri |Illinois :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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