Job Description
Vacancy for Lead Consultant Regulatory Affairs at Genpact Limited.
Organization | Genpact Limited |
Post Name | Lead Consultant Regulatory Affairs |
Job Location | Mumbai |
Official Website | https://www.genpact.com/ |
Job Title/Position:
Lead Consultant – Regulatory Affairs-LIF007298
Job Overview:
Job vacancy for Science, Pharmacy
Job Location:
Mumbai
What are the Key Responsibilities?
Consumer CMC :
- 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
Additional :
- 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.
What are the Educational Qualification(s) for Regulatory Affairs at Genpact Limited?
B.Sc. / M.Sc. / B. Pharmacy / M. Pharmacy
What are the Preferred Skills required for this Job/Position?
- 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.
Related:
Research Associate at GBPIHED Recruitment 2022
Detailed notice
https://genpact.taleo.net/careersection/sgy_external_career_section/jobdetail.ftl?job=882982