Genpact Limited, a global leader in business process and technology management services, leverages the power of smarter processes, smarter analytics and smarter technology to help its clients drive intelligence across the enterprise. Genpacts Smart Enterprise Processes (SEP) framework, its unique science of process combined with deep domain expertise in multiple industry verticals, leads to superior business outcomes.
Post : Lead Consultant - Regulatory Affairs-LIF007298
Job Description
• Responsible for implementing CMC regulatory strategies for assigned consumer products in accordance with global regulations, guidances and defined regulatory strategies.
• Responsible for the writing of CMC quality documents for the dossier and/or the entire module 3 from raw data.
• Review and evaluation of existing quality documentation and assessment of required updates during Project Renewals.
• Preparation of Quality Overall Summaries (QOS);
• Compilation of dossiers for launch applications for marketing authorization and new drug applications in Global markets.
• Submission of relevant sections in Annual Reports for US Market.
• Preparing RA expert response for deficiency letters from various regulatory authorities;
• Assessment of registration documentation for consumer products as per the current Health Authority requirements.
• Knowledge of review and assessment of manufacturing, analytical, validation and stability documents.
• Post-approval submission knowledge for EU markets
• 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.
Candidate Profile
• B.Sc. / M.Sc. / B.Pharmacy / M.Pharmacy
• Expertise in VeevaVault will be a plus point.
• Ability to prioritize tasks to meet deadlines and work with team when help is needed.
• Ability to identify problems and work with team to formulate a potential course of action.
• Must demonstrate oral and written communication skills and the ability to communicate issues in a succinct and logical manner.
• Overall candidate should have decision-making, research and analytics approach and in numbers.
• Capability to handle multiple priorities and balance work to achieve business goals.
• Good people and customer handling skills
• Effective leadership, communication, and interpersonal skills.
• Adhere to our principles and values.
Additional Information
Qualification : B.Sc. / M.Sc. / B.Pharmacy / M.Pharmacy
Location : Mumbai
Industry Type : Pharma / Healthcare / Clinical research
End Date : 20th May, 2022
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