Novo Nordisk Hiring Regulatory Professional I Opportunity in Bangalore

Regulatory Professional I Opportunity

Location: Bangalore, India

Job Category: Reg Affairs & Safety Pharmacovigilance

Brief Position Description:

As a Regulatory Professional I at Novo Nordisk, you will play a crucial role in ensuring regulatory compliance for early phase products and managing product life cycles. You will support in creating regulatory strategies and provide input to all regulatory submissions to Health Authorities worldwide.

Responsibilities:

• Support and provide input to regulatory submissions, including MAA/NDA/BLA, CTA/IND, PIP/PSP, pharmacovigilance documents, renewals, and post-approval changes.
• Assist in planning and conducting regulatory interactions with Health Authorities.
• Develop regulatory strategy and maintain Regulatory Affairs Submission Plan (RASP).
• Establish and maintain core labeling, including tCCDS/CCDS and European labeling.

Qualifications:

• Master of Science (life sciences) or PhD with 7+ years of relevant regulatory experience preferred.
• Strong understanding of regulatory science and requirements in various regions including EU, US, China, Japan, etc.
• Experience in life cycle management, label development, health authority interactions, and device development.
• Proficiency in regulatory intelligence and project management.
• Understanding of the R&D value chain in the pharmaceutical industry.

About the Department:

The Regulatory Affairs department at Novo Nordisk plays a vital role in ensuring the compliance of medicines and devices. We value diversity and expertise, creating a collaborative environment where professionals from various backgrounds come together to make a difference.

Working At Novo Nordisk:

Novo Nordisk is committed to defeating diabetes and other serious chronic conditions. Our focus is on translating unmet medical needs into innovative medicines. By combining innovation and commercial excellence, we aim to transform bold ideas into life-saving medicines.

Contact: If you believe you are a match for the above requirements, please apply using our online application tool.

Apply Now: Apply here