Associate Regulatory Specialist

Novo Nordisk

Associate Regulatory Specialist managing regulatory submissions in diabetes for Novo Nordisk. Collaborating with health authorities and leading submissions in major markets.

Posted 6/4/2026full-timeBangalore • 🇮🇳 IndiaJuniorMid-LevelWebsite

Tech Stack

Tools & technologies

Vault

About the role

Key responsibilities & impact

Develop and execute Regulatory Affairs Submission Plans in Vault RIM
Prepare and publish regulatory files
Manage regulatory submissions and interactions across major markets
Plan and conduct engagements with health authorities
Establish and maintain target CCDS/CCDS
Identify and develop better practice in regulatory documentation and strategies

Requirements

What you’ll need

A PhD, Master's or Bachelor's degree in life sciences, with 7–9+ years of relevant Regulatory Affairs experience
Strong expertise across several regulatory affairs disciplines such as regulatory science & requirements (EU, US, China, Japan)
Life Cycle Management, label development, Health Authority interactions, device development, regulatory intelligence and therapeutic area knowledge
Submission experience across major markets (China, Japan, US, EU)
Excellent written and spoken English, with strong cross-functional communication skills

Benefits

Comp & perks

Opportunities to learn and develop
Health insurance
Retirement plans

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory affairsregulatory submissionsregulatory documentationlabel developmentlife cycle managementregulatory intelligencetherapeutic area knowledgesubmission experience

Soft Skills

cross-functional communicationwritten communicationspoken communication

Certifications

PhDMaster's degreeBachelor's degree