Novartis Hiring For Specialist – RegOps IM at India Full Time

Job Description2023 will see Sandoz become a standalone organization! As a global market leader in Generics and Biosimilar medicine, Sandoz is stepping forward from a position of strength! Those joining Sandoz in the coming months will help shape the future of the company, it’s growth, innovation, culture and how Sandoz impacts the lives of millions. These will be careers with genuine impact! This is one such role! Major Accountabilities:

• Knowledge of ICH and eCTD guidelines governing regulatory submissions (eCTD, ACTD and NeeS) for product registration.
• Perform document level publishing activity across EU, US, CA and MoW for Initial MA and lifecycle management activities including variations and renewals.
• Manage troubleshooting of documents and perform quality checks for submission ready documents as per the agency guidance.

Collaborating closely with the global functions to ensure alignment on priorities and timelines for regulatory submissions.

• Effectively communicates difficult issues both verbally and in writing to build alignment around a complex situation.

Providing quality and timely deliverables to meet the Health Authority timelines.

• Works independently with minimal supervision on common publishing tasks.
• Participates actively or through guidance/oversight in continuous process improvement initiatives.
• Demonstrates deep understanding of the business value of quality and compliance, and the implications and risks of non-compliance.
• Flexibility to adapt to a changing environment.

Diversity & Inclusion / EEOWe are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Minimum RequirementsWorks independently with minimal supervision on common publishing tasks.

• Participates actively or through guidance/oversight in continuous process improvement initiatives.
• Demonstrates deep understanding of the business value of quality and compliance, and the implications and risks of non-compliance.