-This role involves liaising with all relevant stakeholders, departments, and sites for the coordination of document requests in support of submissions in these markets. -Will assess, Manage and track changes for Asian countries/Philippine/Thailand & facilitate regulatory assessment within the RA dept. -Will be responsible for compilation of dossier /Renewals/Variations /Query responses etc. -Compile &Maintain regulatory documentation database or Systems. - Review of data /report that will be incorporated into regulatory submission. Essential duties/Responsibilities - - Coordination with Sites/dept./CMO for documents required for dossier compilation /Renewal/Variation/Query responses etc. - Assess, Manage & track Change Control for Asian countries/Philippine/Thailand. - Review websites for relevant updates or notification for new regulation & guidance document. - Work independently with minimum supervision. Key Competencies (Knowledge, Skills, Abilities) - Professional demeanour all times to interface effectively with all internal/External stakeholders - Excellent Verbal and Written communication skills - Proficiency in MS office, Outlook, Excel - Effectively Prioritize competing tasks - In addition, experience in handling PHARMA Reddy software will be considered an added advantage. This software is widely used in the pharmaceutical industry for various purposes, including data management and regulatory compliance.
