The role coordinates cross-functional activities from due diligence through filing, approval and commercialization, ensuring successful integration of licensed products into the company's portfolio.
Regulatory submission of new products, variations, response to queries, Life cycle management for US and OAM region through preparation of quality dossiers enabling timely approvals.
To conduct audits and assessments of manufacturers of In Vitro Diagnostic Medical Devices (IVDs) against applicable regulatory requirements, quality management system standards, and conformity assessment procedures.
IOL Chemicals and Pharmaceuticals Limited is a purpose and service-driven Active Pharma Ingredients (API) Products, Intermediates and Specialty Chemicals Company. Driven by principles of excellence, successful innovation and global leadership
The Regional Centre for Biotechnology (RCB) is an institution of national importance and a statutory body established by the Department of Biotechnology, Government of India. It functions as a UNESCO Category II Centre with regional and global partnerships. RCB’s primary mandate is to provide world-class education and training, and to conduct innovative, interdisciplinary research in biotechnology to develop high-quality human resources in a globally competitive research environment.
Interview for ‘Project Research Associate-I’ Position
Maintain safety tracking systems and ensure timely completion of assigned activities and deliverables. Conduct MedDRA coding, drug coding, and maintenance of drug dictionaries as required.
Responsible for Regulatory Affairs activities in India and neighbouring markets, encompassing product registrations, regulatory submissions, approvals, renewals, lifecycle management, regulatory intelligence, and liaison with Health Authorities.
Post Graduate Degree, including the integrated PG degrees, in any branch of Life Sciences with five (5) years’ post qualification experience in clinical trial monitoring.
MSc. in Life Sciences or related natural science disciplines from recognized Universities or equivalent, with at least 60% marks. Regional Centre for Biotechnology