Associate Regulatory Affairs I – Clinical Trials & Product Lifecycle Management
Location: Bengaluru, Karnataka, India
Department: Regulatory Affairs
Company: Novo Nordisk India Pvt Ltd
Employment Type: Full-Time
Job Overview
Novo Nordisk is hiring an Associate Regulatory Affairs professional to support clinical trial submissions, regulatory approvals, and lifecycle management activities across India. This role focuses on ensuring timely approvals for clinical trials, new products, and variations while maintaining strict compliance with local regulations, global standards, and internal procedures.
Key Responsibilities
Prepare, compile, and submit clinical trial applications and regulatory documentation to local health authorities. Manage trial maintenance activities including renewals, protocol amendments, site additions, and regulatory correspondence. Support submissions for new products, medical devices, and lifecycle variations to maintain valid licenses. Maintain accurate records, trackers, and electronic repositories for all regulatory submissions and ensure timely archiving. Assist in evaluation and documentation of safety updates and lifecycle changes, including labeling and artwork implementation. Contribute to regulatory intelligence by monitoring updates in local requirements and sharing insights with stakeholders. Act as a point of contact for selected regulatory authority interactions, including State FDA-related activities. Ensure all tasks are performed in compliance with company SOPs, ethical standards, and regulatory guidelines.
Eligibility Criteria
Bachelor’s degree in Pharmacy or a related life sciences field is required. A Master’s degree in Regulatory Affairs is preferred. Candidates must have a minimum of 2 years of experience in Regulatory Affairs or a related pharmaceutical domain.
Required Skills & Competencies
Strong knowledge of clinical trial application processes and regulatory submission requirements. Understanding of product lifecycle management and compliance frameworks. Excellent attention to detail, documentation, and organizational skills. Ability to manage multiple priorities and meet deadlines. Strong communication and stakeholder coordination abilities. Familiarity with regulatory systems and electronic submission tools is an advantage.
Why Join Novo Nordisk
Opportunity to work with a global healthcare leader focused on improving patient outcomes. Exposure to end-to-end regulatory processes across clinical and commercial portfolios. Collaborative and quality-driven work environment. Continuous learning and career growth opportunities within a purpose-driven organization.
Application Deadline: 27 March 2026
About Novo Nordisk
Novo Nordisk is a globally recognized healthcare company with over 100 years of expertise in addressing chronic diseases. The organization is committed to innovation, patient-centric solutions, and maintaining the highest standards of quality and ethics.
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