ManagerSr. Manager - Regulatory Affairs

Summary

This position reports to the

Functional Area

Head, Global Regulatory Affairs. The incumbent is responsible for supporting the development and implementation of regulatory strategies and works closely with cross‑functional asset teams to prepare, review, and submit regulatory filing documents, manage documentation systems, and maintain interactions with regulatory agencies.

• Bachelor of Science Degree in a relevant area is required. Advanced science degree is preferred.
• RAC certification or other equivalent is preferred.

• Minimum Bachelor’s degree in a scientific or related discipline, 5+ years of pharmaceutical industrial experience, at least 3 years of regulatory CMC experience with US product development.
• Deep knowledge of US and EU regulations for biosimilars is preferred.
• Deep knowledge of regulations for drugs and biologics.
• Familiarity with GLP/GCP/GMP, clinical laboratory regulations, and licensing.
• Experience in various regulatory submissions and communication with regulatory agencies. Hosted communication with the agencies on clinical development plans, clinical design and other clinical aspects (including document package writing, meetings and discussions with the agency, etc.) is preferred.
• Led at least one drug IND application in the US and got it approved. Experience in endocrine drugs such as insulin and GLP-1 is preferred.
• Experience in working in a multi‑culture/multi‑countries environment is preferred.

• Demonstrated ability to manage multiple and diverse projects concurrently.
• Demonstrated ability to develop positive relationships and collaborations.
• Strong analytical skills; a strategic thinker, planner, and implementer.
• Ability to operate independently with minimal supervision.
• Strong proficiency in major Microsoft Office products (i.e., Word, Excel, PowerPoint, Project).
• Enthusiastic, genuine, ethical, fair, and loyal to the organization and its vision and goals.