Novo Nordisk Regulatory Specialist job vacancy at Bangalore, Karnataka

Regulatory Specialist

Category:  Reg Affairs & Safety Pharmacovigilance
Location:  Bangalore, Karnataka, IN
  
Department: Regulatory Affairs Rare Endocrine Disorders

Are you passionate about ensuring regulatory compliance for early phase products and/or managing product life cycle and amendments? Do you want to play a crucial role in keeping patients safe and ensuring Novo Nordisk’s license to operate by supporting in creating regulatory strategies?

We are looking for a skilled colleague who will be instrumental in creating regulatory strategies in the most efficient way.

If you are detail-oriented, have strong communication skills, and are ready for a challenging and rewarding career, read on and apply today for a life-changing opportunity.

The Position:

As a Regulatory Specialist Global Regulatory Lead (GRL) at Novo Nordisk, you will have the following responsibilities:

Regulatory Submissions: Plan and execute all regulatory submissions worldwide, including strategy development, document creation, file preparation, publishing, distribution, and response to health authorities.
Regulatory Interactions: Plan and conduct interactions with health authorities, including meeting preparation, rehearsal, and minute-taking.
Core Labeling: Develop and maintain core labeling, ensuring alignment with business opportunities and regulatory requirements throughout the product lifecycle
Global Regulatory Lead: Assume leadership for early development projects (G0 to G2), developing regulatory strategies in line with NN Global Project Framework. Serve as the Regulatory Affairs representative in the Project Core Team and Global Project Team, leading and managing all regulatory activities and ensuring alignment with project objectives.
Serve as the Regulatory Affairs representative in the Global Project Team (GPT)

Qualifications:

To be successful in this role, we are looking for candidates with the following qualifications:

Preferred Master of Science (life sciences) relevant experience and/or PhD with 12+ years of relevant regulatory experience
In-depth knowledge of regulatory science and requirements in multiple regions including EU, US, China, Japan, and others.
First-hand experience in life cycle management, label development, health authority interactions, and device development.
High proficiency in regulatory intelligence and therapeutic area knowledge.
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, real-world evidence, and proficiency in written and spoken English.

APPLY NOW