Novo Nordisk looking for Associate Regulatory Professional

Novo Nordisk is a global healthcare company with 89 years of innovation and leadership in diabetes care. The company also has leading positions within Haemophilia care, growth hormone therapy and hormone replacement therapy.

Post : Associate Regulatory Professional I

Job Description
• Extend support on the compiling, submission, and approval of Country Specific Submissions files for the responsible countries (NDA, LCM & post approval changes).
• Support affiliates in updating local requirements based on regulatory agencies guidance and input from affiliates/distributors.
• Manage working relationships with key stakeholders.
• Ensure compliance with regulatory requirements and provide strategic product direction to teams.
• Interact and negotiate with regulatory agency personnel to expedite approval of pending registrations and respond to any questions.
• Serve as a regulatory liaison on the project team throughout the product lifecycle and ensure regulatory impact assessments of production and label changes.

Candidate Profile
• Minimum 2+ years of experience in Regulatory Affairs or a related function within the pharmaceutical industry
• Master’s degree in science, Pharmacy, Medicine, or a relevant field.
• Regulatory Affairs Expertise
• Intermediate knowledge of pharmaceutical regulatory frameworks and industry landscape.
• Familiarity with global and regional regulatory guidelines and compliance requirements.
• Understanding of Regulatory IT systems and tools used in submission and compliance processes.
• Cross-functional business understanding within Regulatory Affairs and related domains.

Additional Information
Experience : Minimum 2+ years
Qualification : M.Pharm, MSc
Location : Bangalore, Karnataka
Industry Type : Pharma/ Healthcare/ Clinical research
Department : IOSO Regulatory Affairs – OCE
End Date : 14th April 2025