Regulatory Affairs Executive

Job Description

Company Description NV REMEDIES PVT LTD specializes in the exploration, formulation, and third-party production of generic drugs, essential medicinal compounds, and biosimilars. We lead in creating proprietary, patented products and manufacturing processes, enabling effective marketing and distribution across global markets. Additionally, we offer consultancy services to pharmaceutical firms, including regulatory guidance, Quality Management System implementation, and comprehensive regulatory assistance. For nearly 30 years, we have been transforming innovative ideas into life-saving medical solutions, covering the full lifecycle of pharmaceutical product development. Qualifications Skills in Regulatory Documentation and Dossier Preparation Understanding of Regulatory Requirements and Regulatory Compliance Proficiency in managing Regulatory Affairs Excellent written and verbal communication skills Ability to work independently and as part of a team Experience in the pharmaceutical industry is a plus Bachelor's degree in Pharmacy Role Description This is a full-time on-site role located in Navi Mumbai for a Regulatory Affairs Executive. The Regulatory Affairs Executive will be responsible for preparing regulatory documentation, ensuring compliance with regulatory requirements, managing dossier preparation, and overseeing regulatory affairs. Preparation of Dossiers CTD, eCTD preparation for ASIA, CIS, AFRICA markets. Full awareness of ASIA, CIS, AFRICA countries regulatory authorities guidelines and ICH guidelines. Ensure that a company's products comply with the regulations of the regions where want to market keep up to date with national and international legislation, guidelines and customer practices. Respond to queries from regulatory agencies of CIS, ASIA, Africa regions. Collect, collate and evaluate/review of documents from the manufacturing sites. | Application of new product licenses and licenses and GMP renewals. Prepare submissions of license variations and renewals to strict deadlines. Also awareness of CDSCO & DCGI guidelines. Products variations and manufacturing site registrations and renewal approvals work Preparing & Checking of product artworks labels and patient information leaflets Maintaining proper regular documents database management Show more Show less