Manger Regulatory Affairs Job in Mumbai at Genpact

Genpact is hiring for the position of Manger Regulatory Affairs!

Responsibilities of the Candidate:

• Change management process of CCDS, Non-CCDS and Annual reportable labelling changes.
• Analysis of competitor information (e.g., labels, approval packages) for regulatory policy projects and/or labelling projects
• Escalate, notify, and resolve any issues that may impact final labelling submission.
• End to end responsibility of labelling for product registered in the US market.
• Responsible for maintaining internal tracker for CCDS, Non-CCDS and Annual reportable labelling changes and submissions.

Requirements:

• B. Pharmacy / M. Pharmacy / B.Sc. / M.Sc.
• Ensure adherence to the specific project specifications or standards throughout the lifecycle of the submission.
• Effective time management and organizational skills to efficiently manage multiple time-sensitive assignments simultaneously.
• Demonstrates deep understanding of the business value of quality and compliance, and the implications and risks of non-compliance. Adjusts behaviors to drive high quality deliverables.
• Demonstrates the ability to independently solve trouble shoot problems that arise within job responsibilities and expectations and takes a new perspective using existing solutions.
• Effectively communicates difficult issues both verbally and in writing to build alignment around a complex situation and process.
• Flexibility to adapt to a changing environment, keeping current with new and updated processes and procedures.
• Depending on experience level, mentor newly hired staff or lead a team of junior staff.
• Flexibility in responding to changing priorities or dealing with unexpected events.
• Capability to handle multiple priorities and balance work to achieve business goals.