The Role demands expertise with demonstrating ability to execute responsibility in a highly regulated & process driven environment, the Person will be responsible for all the activities related to following things:
1.Responsible for overseeing the project progress, managing the team, ensuring the project stays on schedule and maintaining communication with stakeholders.
2.Responsible for implementing CMC regulatory strategies for assigned consumer products in accordance with global regulations, guidance and defined regulatory strategies.
3.Responsible for the writing of CMC quality documents for the dossier and/or the entire module 3 from raw data, quality control of the CMC documents ensuring the project meets the goals and standards.
4.Review and evaluation of existing quality documentation and assessment of required updates during Project Renewals.
5.Preparation of Quality Overall Summaries (QOS) for drug product and drug substance.
6.Compilation of dossiers for launch applications for marketing authorization and new drug applications in Global markets.
7.Submission of relevant sections in Annual Reports for US Market.
8.Preparing RA expert response for deficiency letters from various regulatory authorities.
9.Assessment of registration documentation for consumer products as per the current Health Authority requirements.
10.Knowledge of review and assessment of manufacturing, analytical, validation and stability documents.
11.Post-approval submission knowledge for EU markets.
About Company
Genpact is a global professional services firm that offers a wide range of digital transformation services and solutions. With a presence in over 30 countries, Genpact leverages its deep domain expertise in operations and analytics to help businesses transform their operations, improve efficiency, and enhance customer experience. The company combines digital technology, data science, and operational excellence to deliver business outcomes across various industries, including banking, insurance, manufacturing, and healthcare. Founded in 1997 as a subsidiary of GE, Genpact has grown into an independent, NYSE-listed company with a diverse workforce of over 90,000 employees globally.
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