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Director - Regulatory Affairs Cmc

10+ years
₹65 – ₹85 LPA
10 July 19, 2025
Job Description
Job Type: Full Time Education: M.Sc./M.Pharm/PhD 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

Location: Bangalore, India
Position: Director – Regulatory Affairs CMC (Diabetes & Obesity)
Experience Required: 10+ years (including 7+ years in leadership roles)
Company: Novo Nordisk
Application Deadline: 2nd August 2025

About Novo Nordisk:
Novo Nordisk is a global healthcare leader committed to defeating serious chronic diseases with bold innovation and patient-focused solutions. With over a century of scientific excellence and a unique culture of collaboration, Novo Nordisk is reimagining the way healthcare impacts lives worldwide. At our Global Business Services (GBS) center in Bangalore, we support global operations through strategic regulatory leadership and excellence.

Role Overview:
We are hiring a Director – Regulatory Affairs CMC (Diabetes & Obesity) to lead and expand our high-performing RA CMC Life Cycle Management (LCM) team. This strategic role focuses on driving regulatory strategy, compliance, leadership development, and stakeholder engagement across multiple geographies, ensuring the continued success of Novo Nordisk’s diabetes and obesity product portfolio.

Key Responsibilities:

  • Lead and develop a large, global team of specialists and leaders focused on regulatory CMC LCM for marketed diabetes and obesity products.

  • Implement team strategy, foster a coaching and collaborative culture, and ensure optimal planning and resource utilization.

  • Own and oversee people processes including recruitment, development, performance evaluations, and succession planning.

  • Ensure local and global compliance with regulatory standards and maintain the Quality Management System (QMS).

  • Drive performance on the Business Scorecard (BSC) by meeting timelines and delivering strategic outcomes.

  • Represent the RA CMC & Device function in strategic initiatives, global forums, audits, and collaborations.

  • Promote cLEAN (continuous improvement) mindset and innovation in regulatory operations.

  • Engage cross-functionally with QA, manufacturing, supply chain, production development, affiliates, and senior management.

  • Serve as a thought leader and subject matter expert across the value chain, influencing decision-making for regulatory success.

Candidate Requirements:

  • Master’s degree in Life Sciences (Engineering, Pharmacy, Chemistry, or similar).

  • Minimum 10 years of experience in the pharmaceutical industry, with significant exposure to global regulatory CMC, manufacturing, or QA.

  • At least 7 years of leadership experience, ideally including experience leading leaders.

  • Strong stakeholder engagement skills with senior management in global production and regulatory contexts.

  • Deep understanding of regulatory standards, risk management, and compliance frameworks.

  • Ability to lead complex initiatives, build high-performing teams, and inspire organizational growth.

  • Excellent communication, negotiation, and decision-making skills.

What We Offer:

  • A leadership role in a globally recognized biopharmaceutical company.

  • An opportunity to influence global regulatory strategy and innovation in CMC lifecycle management.

  • Work with experienced colleagues in an inclusive, purpose-driven culture.

  • Long-term career development in a company dedicated to health, science, and sustainability.

How to Apply:
Apply online via the official careers portal by the 2nd of August 2025.

Estimated Salary: ₹65 – ₹85 LPA (based on industry benchmarks for Director-level Regulatory Affairs roles in India with global scope)