India's DMPLOI - Jobs & Networking App
Novo Nordisk
Novo Nordisk Global Business Services (GBS) is inviting applications for the position of Associate Regulatory Specialist in Bangalore, Karnataka. This is an excellent opportunity for experienced Regulatory Affairs professionals to join one of the world’s leading healthcare companies and contribute to bringing innovative diabetes therapies to patients globally.
Job Overview
- Position: Associate Regulatory Specialist
- Department: Regulatory Affairs & Safety Pharmacovigilance
- Location: Bangalore, Karnataka, India
- Company: Novo Nordisk Global Business Services (GBS)
- Experience Required: 7–9+ Years
- Qualification: Bachelor’s, Master’s, or PhD in Life Sciences
- Application Deadline: 18 June 2026
Key Responsibilities
As an Associate Regulatory Specialist, you will be responsible for:
Global Regulatory Submissions
- Develop and execute Regulatory Affairs Submission Plans.
- Prepare and publish regulatory dossiers and submission files.
- Manage MAA, NDA, BLA, CTA, IND, PIP, PSP submissions and renewals.
- Handle post-approval variations and lifecycle management activities.
- Prepare pharmacovigilance documents such as DSUR, PSUR, and RMP.
Health Authority Interactions
- Coordinate and manage interactions with global regulatory authorities including FDA, EMA, PMDA, and others.
- Prepare meeting requests, briefing packages, and regulatory responses.
- Lead meeting rehearsals and document official meeting outcomes.
Core Labeling Activities
- Establish and maintain Company Core Data Sheets (CCDS).
- Support European and US labeling strategies.
- Align product labeling with commercial and market access requirements.
Regulatory Process Improvement
- Drive continuous improvement initiatives within Regulatory Affairs.
- Develop best practices and enhance regulatory documentation processes.
Regulatory Due Diligence
- Lead regulatory due diligence assessments for business development and strategic projects.
Clinical Regulatory Support
- Participate in cross-functional clinical project teams.
- Provide regulatory expertise for submissions across major global markets including the US, EU, China, and Japan.
Eligibility Criteria
Candidates should possess:
- Bachelor’s, Master’s, or PhD degree in Life Sciences or related disciplines.
- 7–9+ years of Regulatory Affairs experience within the pharmaceutical or biotechnology industry.
- Strong understanding of global regulatory requirements across the US, EU, China, and Japan.
- Experience in lifecycle management, health authority interactions, labeling development, and regulatory intelligence.
- Knowledge of pharmacovigilance, clinical development, digital health, and patient access.
- Excellent communication and stakeholder management skills.
- Ability to work effectively in a multicultural and cross-functional environment.
Why Join Novo Nordisk?
Novo Nordisk is a globally recognized healthcare company dedicated to defeating serious chronic diseases. Employees benefit from:
- Exposure to global regulatory projects.
- Career growth and learning opportunities.
- Collaborative and inclusive work culture.
- Opportunities to work with international regulatory authorities.
- Competitive compensation and employee benefits.
Application Deadline
18 June 2026
Applications are reviewed on a rolling basis. Interested candidates are encouraged to apply as early as possible.
If you are an experienced Regulatory Affairs professional looking to advance your career with a global pharmaceutical leader, this opportunity at Novo Nordisk could be the perfect next step. Apply now and contribute to delivering innovative diabetes treatments to patients worldwide.
APPLY HERE
To apply for this job please visit careers.novonordisk.com.
