We challenge the status-quo, invent, and re-imagine the healthcare industry using deep medical/scientific understanding, bleeding-edge technology, and bold audacious thinking. At Indegene, our teams do their most profound work, think and imagine without limits, and transform the once traditional industry into a modern intelligent enterprise.
Post : Regulatory Associate
Job Description
Role Purpose : Candidate will need to plan, prepare, and submit high-quality regulatory dossiers to the Health Authorities of ASEAN markets - Australia, Cambodia, Hong Kong, Korea, Malaysia, Macao, Indonesia, Pakistan, Philippines, Singapore, Taiwan Thailand, Vietnam
Experience with global regulatory submission formats and ACTD/eCTD/ /NeeS/Paper dossiers format, including familiarity with submission publishing activities is required.
Principal Responsibilities & Accountabilities :
• Basic medical/pharma/scientific knowledge that can be applied in developing regulatory submission documents
• Thorough knowledge of major HA global/regional/national country requirements/regulatory affairs procedures for initial submission, licensing, post approval submission management
• Markets Handled: Australia, Cambodia, Hong Kong, Korea, Malaysia, Macao, Indonesia, Pakistan, Philippines, Singapore, Taiwan Thailand, Vietnam
• Prepare and compile global regulatory dossiers in ACTD, eCTD and non eCTD format in accordance with ASEAN HA legislations and client specific requirements
• Prioritise, plan, and monitor submissions for allocated products while documenting and informing involved parties of progress
• Able to support and prepare Module 1 documents - submission form, cover letter, notification forms, comparison tables for regulatory submission
• Assist in the preparation and submission of post-approval regulatory filings, variations, and renewal applications
• Hands-on experience on regulatory document management systems and publishing tools
• Able to create submission packages in line with regulatory strategy for pharmaceutical drugs, vaccines, generics, GMO’s, and biological products
• Coordinate with cross-functional teams, including R&D, quality assurance, and manufacturing, to gather necessary information and documentation for dossier preparation
• Regular tracking and maintaining the submission trackers
• Stay updated with evolving regulatory requirements and industry trends and able to extract regulatory intelligence information (requirements for initial filing, drug/device/cosmetic/food registration etc.)
• Participate in trainings and learn through hands-on experience on the job
• Exhibit flexibility in moving across new projects and preparing multiple document types
• Continuously enhance and maintain knowledge of various regulatory guidelines for different deliverables by doing various assignments
• Volunteer in training programs to develop skills in areas relevant to the job in addition to the areas of interest
Additional Information
Experience : Required 2-4 years of experience in ASEAN markets
Qualification : BPharm / MPharm/ Pharm D/ MSc
Location : Bangalore
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 20th December, 2023
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