Job Description

Role & responsibilities Job description Ensure that a company's products comply with the regulations of the regions. Keep up to date with national and international legislation, guidelines and customer practices Respond to queries from Centre for Veterinary Medicines (CVM). Collect, collate and evaluate scientific data from FR&D, AR&D and DQA. Develop and write clear arguments and explanations for new product licences and licence renewals at R&D site. Prepare submissions of licence variations and renewals to strict deadlines as per CVM. Monitor and set timelines for licence variations and renewal approvals Advise scientists (AR&D, FR&D, Pkg.-R&D) on regulatory requirements. Provide strategic advice to senior management throughout the development of a new product Review company practices and provide advice on changes to systems if any. Liaise with manager, and make presentations to, regulatory authorities, if any. Negotiate with regulatory authorities for marketing authorisation Take part in the development of marketing concepts and approve packaging and advertising before a product's release. Prepare the CTD sections of the dossier and ensure timely filing as informed by the functional head and Head -R&D. Review the data and check for its alignment and compliance from regulatory point of view as per CVM. Ensure the regulatory filing grid as shared by Functional head and Head-R&D is met on timely way and in complete regulatory compliance. Collaborate with FR&D, AR&D, Pkg-R&D on regular basis and together ensure the timely filing of products.