Responsibilities As a Regulatory Specialist Global Regulatory Lead (GRL) at Novo Nordisk, your responsibilities will include:
- 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 qualify for this role, candidates should have:
- Master of Science (life sciences) or PhD with 12+ years of relevant regulatory experience.
- In-depth knowledge of regulatory science in multiple regions.
- Experience in life cycle management, label development, and health authority interactions.
- Project management skills and familiarity with the pharmaceutical industry.
About the Department The Regulatory Affairs department at Novo Nordisk plays a crucial role in ensuring compliance and bringing innovative products to market. They value diversity and expertise, fostering a collaborative environment for professionals from various backgrounds.
Apply online
[caption id="attachment_75131" align="aligncenter" width="1200"] Novo Nordisk Hiring Regulatory Specialist in Bangalore[/caption]Working at Novo Nordisk Novo Nordisk is a global healthcare leader with a commitment to defeating chronic diseases. With a strong legacy in diabetes and a focus on innovation, they impact millions of lives daily. Join a team dedicated to improving patient lives and making a global impact.
Contact and Deadline If you meet the qualifications and are ready for this role, apply online before 17th May 2024 using Novo Nordisk's application tool. https://pharmastuff.org.in/job/novo-nordisk-hiring-regulatory-specialist-in-bangalore