Job Opportunity: Regulatory Professional II at Novo Nordisk

Novo Nordisk, a global healthcare leader with nearly nine decades of innovation in diabetes care, is seeking a Regulatory Professional II to join the RA CMC & Device team in Bangalore. Our team comprises over 60 experienced professionals dedicated to regulatory processes covering Chemistry Manufacturing Control (CMC), Medical Device Reporting (MDR), submission of regulatory files, product registrations, and life cycle management across various therapeutic areas including biotech, rare diseases, diabetes, obesity, and medical devices.

About the Role

As a Regulatory Professional II, you will play a crucial role in ensuring timely submissions to Health Authorities worldwide and maintaining the CMC part of the core regulatory file. Key responsibilities include submission planning, regulatory strategy development, document creation and review, managing change requests and deviations, responding to health authority queries, annual reporting, and marketing authorization maintenance globally. Additionally, you will support NDA, renewals, post-approval changes, and have hands-on experience with Veeva Vault (Submission & Registrations). Stakeholder management and effective communication will be essential aspects of this role.

Candidate Profile

  • Experience: 7-8 years within Regulatory Affairs
  • Education: Graduate/Postgraduate degree in Life Sciences/Chemistry/Pharmacy/Medicine/Biotechnology Engineering
  • Experience in both global and affiliate environments is preferred
  • Comprehensive understanding of end-to-end regulatory processes and life cycle management
  • Strong negotiation skills, project management skills, and ability to articulate facts confidently
  • Proactive, initiative-taking, and capable of managing multiple priorities effectively
  • High cultural sensitivity and comfortable collaborating with diverse teams across multiple time zones
  • Excellent written and spoken communication skills

Additional Information

  • Experience: 7-8 years
  • Qualification: M.Pharm, M.Sc
  • Location: Bangalore
  • Industry Type: Pharma/Healthcare/Clinical Research
  • Functional Area: Regulatory Affairs & Safety Pharmacovigilance
  • End Date: May 25th, 2024

If you are a dynamic and experienced regulatory professional looking to make a significant impact in a global healthcare company, we invite you to apply. Join us at Novo Nordisk and contribute to our mission of delivering innovative and patient-centric solutions to improve lives worldwide.

Interested candidates are requested to submit their applications before May 25th, 2024.

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