Regulatory professional 1 (Novo Nordisk)

Roles and Responsibilities

The position

As a Regulatory Professional at Novo Nordisk, you will:

• Secure regulatory approvals for new products (NDA and LCM licenses) in due time for specific countries.

• Manage product life cycle activities, including timely submissions, reviewing submission packages, and preparing application forms as per country-specific health authority (HA) requirements.

• Engage with distributors and authorities to ensure product approvals and compliance with local HA requirements.

• Review and manage documentation for tenders and other submissions.

• Update the RA system (Veeva Vault) with product dossier and approval information within agreed timelines.

• Collaborate with affiliates to develop labelling materials, review promotional materials, and ensure compliance with local legislation and standard operating procedures.

• Monitor local regulatory environments and ensure overall regulatory compliance.

• Provide support for post-approval activities and regulatory signals, ensuring alignment with country-specific HA requirements

Qualifications

We are looking for a highly motivated and proactive individual who meets the following qualifications:

• Post-Graduation or comparable degree in science.

• Above 5 years of experience in pharmaceutical industry in Regulatory Affairs.

• 3+ years working with key stakeholders and decision makers outside India in a cross-functional, international environment.

• Experience of working in an Affiliate environment & shared service model preferred

• Experience working in an affiliate environment and shared service model.

• Experience in handling conversations with health authorities.

• Basic project management skills and the ability to manage multiple priorities