Regulatory Professional I at Novo Nordisk
Company:
Novo Nordisk
Global leader in regulatory compliance for new products and amendments.
Position:
Regulatory Professional I
Qualifications:
- M.Sc
- M.Pharm
- Ph.D
- Pharm.D
Experience:
- 7+ years
Salary:
Not disclosed, but very high
Location:
Bangalore, India
Job Description:
Novo Nordisk is seeking a Regulatory Professional I to join the Global Regulatory Affairs team. This role involves collaborating with the Global Regulatory Lead and a team of professionals to advance projects within the Semaglutide portfolio.
Responsibilities:
- Support and provide input for regulatory submissions to Health Authorities globally
- Participate in cross-functional project teams and provide regulatory input
- Drive, coordinate, and follow up on tasks with challenging timelines
- Prepare and submit documents for lifecycle management of marketed products (DSUR, PSUR, RMP updates, IB reviews)
- Develop regulatory documentation for Health Authorities, including clinical trial applications and marketing authorization files
- Interact with stakeholders to ensure alignment between local and global regulatory strategies
- Establish and maintain core labeling and support labeling development throughout the product lifecycle
Qualifications:
- Master of Science (life sciences) or Ph.D. with 7+ years of relevant regulatory experience
- Strong understanding of regulatory science and requirements in regions including EU, US, China, Japan
- Experience in lifecycle management, label development, EU clinical trial applications, and health authority interactions
- Proficiency in regulatory intelligence
- Excellent communication and presentation skills
- Demonstrated project management skills
- Understanding of business management and the R&D value chain in the pharmaceutical industry
- Familiarity with digital health, competitive intelligence, disease understanding, statistics, pharmacovigilance, non-clinical and clinical pharmacology
- Knowledge of patient access and real-world evidence
Contact:
Novo Nordisk HR
📧 careers@novonordisk.com
How to Apply:
Join Novo Nordisk and take your career to the next level!
Job Details:
| Job Title | Regulatory Professional I |
|---|---|
| Experience | 7+ years |
| Location | Bangalore, India |
