Posted:4 days ago|
Platform:
On-site
Full Time
We are inviting applications for the role of Lead Associate or Lead Consultant, Regulatory affairs.
.Responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidance and defined regulatory strategies along with the preparation and review of information required for development of regulatory CMC dossiers for commercial products.
.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 &ldquoNo 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).
.Superior attentiveness to detail & has a strong regulatory background.
Bachelor&rsquos or master&rsquos degree required in science, engineering or related field (advanced degree preferred).
Genpact
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