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Regulatory Professional

3 months ago

Bengaluru, Karnataka, India Novo Nordisk AS Full time

Department: RA CMC Diabetes & Obesity

Are you passionate about your work? Do you strive for process excellence in the most efficient way? Are you a change-maker with an innovative mindset, eager to shape the future? If you excel in what you do, then this role as a CMC Regulatory Professional II is an amazing opportunity for you at Novo Nordisk. Join us for a rewarding experience.

About the department

Regulatory Affairs is vital in ensuring all Novo Nordisk Medicines and Devices comply with regulations and prioritize patient well-being. Collaborating with authorities and internal stakeholders, Regulatory Affairs guides product development, NDA submissions, and lifecycle management. Our diverse Regulatory Affairs team brings valuable perspectives and skills, making it a vibrant, multi-disciplinary environment with rich opportunities for growth.

The Position

As a Regulatory Professional, you will drive timely submissions to Health Authorities globally. Your role involves managing the CMC section of regulatory files and overseeing Life Cycle Management activities.

  • Support submission planning: Develop regulatory strategies, maintain submission plans, and review documents.
  • Manage Regulatory files, Change Requests, Deviations, global HA queries, Annual Reports, and worldwide marketing authorization maintenance.
  • Assist with NDA submissions, Renewals, and Post Approval Changes.
  • Experience with Veeva Vault for Submissions & Registrations.
  • Lead stakeholder management and enhance communication channels for strong relationships.

Qualifications

  • 6+ years in Regulatory Affairs/CMC with a degree in Life Science, Chemistry, Pharmacy, Medicine, or Biotechnology engineering.
  • Global & Affiliate experience.
  • Comprehensive knowledge of Regulatory Processes and Life Cycle Management.
  • Confident, bold personality with strong negotiation and project management skills.
  • Effective communication and persuasion skills.
  • Proactive, initiative-driven, capable of managing multiple priorities.
  • Culturally sensitive, adept at collaborating across time-zones and diverse cultures.
  • Excellent written and verbal communication skills.