Regulatory Professional II

Novo Nordisk

Regulatory Professional II responsible for timely submissions and regulatory excellence at global Health Authorities. Collaborating on Life Cycle Management with a focus on strategic planning and compliance.

Posted 6/9/2026full-timeBangalore • 🇮🇳 IndiaMid-LevelSeniorWebsite

Tech Stack

Tools & technologies

Vault

About the role

Key responsibilities & impact

Make timely submissions to Health Authorities worldwide
Establish and maintain the CMC part of the core regulatory file
Support submission planning by applying regulatory intelligence
Develop regulatory strategy and create the Regulatory Submission Plan
Support the submission of regulatory files and handle Change Requests and Deviations
Respond to RSI/HA queries worldwide
Support NDA roll-outs, Renewals and Post Approval Changes
Work with Veeva Vault to ensure efficient and compliant regulatory operations
Manage stakeholders and strengthen relationships across the business
Collaborate across countries, cultures and time-zones

Requirements

What you’ll need

6+ years of experience within Regulatory Affairs
Graduate or Postgraduate degree in Life-Science, Chemistry, Pharmacy, Medicine or Biotechnology Engineering
Good understanding of end-to-end Regulatory Processes and Life Cycle Management
Strong RA-CMC knowledge and commercial acumen
Diverse regulatory experience across regulated and emerging markets
Experience working in both global and affiliate environments
Bold personality with proven negotiation skills
Excellent project management skills
Highly proactive with the ability to take initiative
Excellent written and spoken English communication skills

Benefits

Comp & perks

Opportunities to learn and develop
Benefits designed with career and life stage in mind

ATS Keywords

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Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

regulatory strategyregulatory submission planningregulatory intelligenceregulatory processeslife cycle managementRA-CMC knowledgenegotiation skillsproject management

Soft Skills

proactiveinitiativestakeholder managementrelationship buildingcollaborationcross-cultural communication

Certifications

Graduate degreePostgraduate degree