Assoc Regulatory Affairs I

Department - Regulatory Affairs  

Organization – Novo Nordisk India Pvt Ltd

Are you passionate about helping bring life-changing medicines and clinical trials to patients by securing timely regulatory approvals? Join Novo Nordisk as a Regulatory Affairs Professional and play a key role in supporting submissions and lifecycle activities across India. If you are ready to work in a purpose-driven environment with high standards of ethics and quality, read on and apply today for a life-changing career.

Purpose of the job

As an Assoc Regulatory Affairs I you would have to secure timely regulatory approvals for clinical trials, new products, medical devices and lifecycle variations, and maintain existing licenses in due time for Novo Nordisk across India.

Roles & responsibilities

• Prepare, compile and submit clinical trial applications and related correspondence to local health authorities.

• Manage trial maintenance activities (e.g., status notifications, renewals, annual updates, protocol amendments, site additions, import license renewals and other required correspondence).
• Support submissions for new products, medical devices and variations for existing products to maintain licenses in due time.
• Receive, archive and support evaluation of safety information and lifecycle changes; support internal workflows needed for compliant labelling/artwork implementation.
• Maintain accurate submission records, trackers and electronic repositories; ensure timely archiving of submissions and acknowledgements.
• Contribute to regulatory intelligence, including updates to local requirements information to keep relevant stakeholders informed.
• Act as a point of contact for selected local authority interactions (e.g., State FDA-related activities), as relevant to the role.
• Ensure all activities are performed in line with company procedures, ethical standards and the Novo Nordisk Way.

Education and work requirements

• A bachelor’s degree in pharmacy (or similar) a Master’s degree in Pharmaceutical Regulatory Affairs is considered an advantage.
• At least 2 years of experience within regulatory affairs or a related role in the pharmaceutical industry.
• Knowledge of clinical trial application processes and product lifecycle maintenance activities.
• Strong attention to detail, good planning skills and the ability to manage multiple priorities.
• Clear communication skills and a collaborative mindset, with commitment to high ethical standards.

About the department

You will join the Regulatory Affairs team supporting Novo Nordisk’s portfolio across India. Working closely with colleagues across Clinical, Medical, Quality, Legal, Supply Chain, Sales and Marketing, you will help ensure that regulatory submissions and lifecycle activities are delivered with quality and in due time. The team operates in a collaborative environment with a strong focus on compliance, continuous improvement and patient safety.