To ensure products are registered according to plan for India and neighbouring markets and maintain appropriate records for product compliance bodies (like CDSCO, MDR2017, IVD directives, CE, BIS ,electrical safety etc.)
To maintain regulatory system update and data compliance on Veeva vault RIMS
To ensure that necessary licenses and certifications are kept updated and renewed as per plan and timely circulations of licenses.
Keeping up to date with company’s product range.
Knowledge of SUGAM portal handling /CDSCOMDOnline.
To coordinate and prepare submission of new, variations and renewal of registration, licenses and tracking.
To assist customer notification including reports to authorities and manufacturing division and in the event of product quality problems, product recall and similar notification.
To ensure product corrective action timely implemented.
To maintain post market vigilance activities records & database (registration master database, customer product complaints, ICCR & product quality issue etc.)
To ensure compliance to relevant environmental, health and safety regulations.
To ensure compliance to code of conduct and business ethics codes.
To maintain ERP product restriction due to regulatory requirements.
To Support Tender submissions by providing Regulatory and Quality documents.
To liaise with internal customer and division for any regulatory updates and changes.
To liaise with regulatory authorities like CDSCO (DCGI office), NIB, NPPA, BIS, MieTY, BGFT etc.
Qualification & Experience
Degree in B.Pharm, M. Pharm , B.Tech in pharmacy
4-6 years of experience in a multinational organization and 5 years of RA and QA in a regional sales and Distribution organization