Novo Nordisk is hiring an Associate Regulatory Affairs I in Bangalore. This is an excellent opportunity for pharmacy professionals looking to build a career in regulatory affairs, clinical trial approvals, and lifecycle management within a global pharmaceutical leader.
If you have experience in regulatory submissions, CDSCO processes, and clinical trial applications in India, this role offers strong career growth in a purpose-driven organization.
Job Overview
- Role: Associate Regulatory Affairs I
- Department: Regulatory Affairs
- Location: Bangalore, India
- Experience: Minimum 2 years
- Industry: Pharmaceutical / Healthcare
Key Responsibilities
- Prepare and submit clinical trial applications to Indian regulatory authorities
- Manage trial lifecycle activities (renewals, amendments, updates)
- Support new product registrations and medical device submissions
- Handle import licenses and regulatory correspondence
- Maintain submission trackers and regulatory documentation systems
- Assist in pharmacovigilance and safety data evaluation
- Ensure compliance with CDSCO and State FDA regulations
- Contribute to regulatory intelligence and policy updates
Qualifications & Eligibility
- Bachelor’s degree in Pharmacy or Life Sciences
- Master’s in Regulatory Affairs (preferred)
- Minimum 2 years of regulatory affairs experience
- Strong knowledge of:
- Clinical trial applications (CTA India)
- Lifecycle management & variations
- Regulatory compliance frameworks
- Skills:
- Attention to detail
- Communication & teamwork
- Multi-tasking and planning
Why Join Novo Nordisk?
- Work with a top global pharma company
- Exposure to clinical trials & regulatory strategy
- Strong focus on ethics, compliance, and patient safety
- Career growth in regulatory affairs and pharmacovigilance
- Collaborative cross-functional environment
Salary & Benefits
- Estimated Salary: ₹6,00,000 – ₹10,00,000 per annum
- Health insurance, global exposure, and learning opportunities
- Work in a high-impact healthcare environment