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Regulatory Professional I

Novo Nordisk
Novo Nordisk
3-5+ years
preferred by company
10 Jan. 29, 2026
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Regulatory Professional I – Regulatory Affairs

Location: Bengaluru, Karnataka, India
Category: Regulatory Affairs & Safety Pharmacovigilance
Department: International Operations Regulatory Affairs
Employment Type: Full-Time

About Novo Nordisk

Novo Nordisk is a global healthcare company with more than a century of innovation in chronic disease management. With a strong presence across international markets, the organization is committed to delivering high-quality, compliant, and timely healthcare solutions worldwide. Novo Nordisk Global Business Services (GBS), India, plays a strategic role in supporting global regulatory operations and portfolio growth.


Job Overview

Novo Nordisk is seeking a Regulatory Professional I to join its International Operations Regulatory Affairs team in Bengaluru. This role is critical in supporting regulatory approvals, product lifecycle management, and post-approval compliance activities across multiple international markets. The position offers exposure to global regulatory frameworks, cross-functional collaboration, and direct interaction with health authorities and affiliates.


Key Responsibilities

  • Secure timely regulatory approvals for new products (NDA) and lifecycle management (LCM) submissions across assigned international markets.

  • Manage product lifecycle activities, including preparation, review, and submission of regulatory dossiers in accordance with country-specific Health Authority requirements.

  • Coordinate with distributors, affiliates, and regulatory authorities to ensure regulatory compliance and approval readiness.

  • Review and manage regulatory documentation related to tenders, variations, and amendments.

  • Maintain accurate and up-to-date regulatory information in Veeva Vault and other regulatory systems within defined timelines.

  • Collaborate with affiliates on labeling development, review of promotional materials, and compliance with local regulations and internal SOPs.

  • Monitor local regulatory environments and provide regulatory intelligence to ensure ongoing compliance.

  • Support post-approval commitments, regulatory signals, and variation activities in alignment with Health Authority expectations.


Experience Required

  • Minimum 5+ years of experience in Regulatory Affairs within the pharmaceutical industry.

  • At least 3 years of experience working in a cross-functional, international regulatory environment involving stakeholders outside India.

  • Proven experience interacting with Health Authorities and managing regulatory submissions.

  • Experience in affiliate-based operations and shared service models is preferred.


Education & Qualifications

  • Postgraduate degree or equivalent qualification in Science, Pharmacy, Life Sciences, or a related discipline.

  • Strong understanding of global regulatory frameworks and submission processes.

  • Basic project management skills with the ability to manage multiple priorities simultaneously.


Key Skills & Competencies

  • Strong regulatory documentation and dossier management skills

  • Excellent stakeholder communication and coordination abilities

  • High attention to detail and compliance orientation

  • Ability to work effectively in a global, matrix-driven organization


About the Department

The International Operations Regulatory Affairs – Bengaluru team is a strategic extension of Novo Nordisk’s global regulatory organization based in Zurich and Copenhagen. The team enables rapid portfolio expansion, high-quality approvals, and sustained regulatory compliance across International Operations.


Why Join Novo Nordisk

  • Be part of a globally respected regulatory organization

  • Gain exposure to international markets and health authorities

  • Work in a purpose-driven company committed to long-term healthcare impact

  • Inclusive work culture with equal opportunity and professional growth


Application Deadline

4 February 2026


Equal Opportunity & Recruitment Disclaimer

Novo Nordisk is an equal opportunity employer and is committed to inclusive recruitment practices. The company does not charge any fees at any stage of the recruitment process. Candidates are advised to remain cautious of fraudulent job offers not originating from official Novo Nordisk communication channels.