Lead Consultant - Regulatory Affairs
Genpact
5 - 10 years
Lucknow
Posted: 06/06/2025
Job Description
Responsibilities
:The core responsibility will be to review the authored documents, compare them with source documents, ensure there are no transcription or formatting errors, no quality errors, and ensure compliance with regulatory guidelines.
Maintaining the quality of documents through quality reviews ensuring No Queries received from Health Authorities
Work on authoring CMC documentation for worldwide marketing of pharmaceutical products for initial registration and life-cycle management under the direction of team scientists.
Experience in reviewing scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented clearly and conclusions are adequately supported by data.
Able to prioritize & execute the project according to the project plan/timelines/schedules.
Work with cross-functional teams to track and follow up outstanding documentation, coordinate on project status & reporting to stakeholders using different communication channels.
Demonstrated oral and written communication skills and the ability to communicate issues in a succinct and logical manner. Strong listening skills.
Demonstrated understanding of related fields (e.g., pharmaceutical manufacturing, analytical testing, and quality assurance).
Ability to generate innovative solutions to problems and effectively collaborate with and communicate with key stakeholders.
Active participation in departmental improvement activities such as system modifications, maintenance of standard operating procedures, internal guidelines, etc.
Demonstrated flexibility in responding to changing priorities, multi-tasking and dealing with unexpected events.
Effective leadership, communication, and interpersonal skills.
Advanced knowledge of MS Office.
Superior attentiveness to detail & has a strong regulatory background.
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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