Regulatory Affairs Executive ..New Era. - Bangalore,"R"

Regulatory Affairs Executive
New Era. - Bangalore, Karnataka

Regulatory Submissions and Approvals Dossier Preparation - Prepare, review quality regulatory dossier and prepare a compliance report of dossier evaluation with reference to the country regulations. To work within the regulatory timelines for dossier submission. Provide the necessary support function: Maintenance of the Product Dossiers, data files, etc. Communication/Coordination with local affiliate members . Regulatory Compliance (Quality Control/Quality Assurance) Compliance Maintenance Provide support to maintain all local marketed products in compliance with local and corporate regulatory requirements. Handling of complaints and Pharmacovigilance activities in the affiliate market for the products: Evaluation, monitoring and reporting via specific system, build better customer platform to bring in Product/ service value addition while working with Affiliate team members. Compliance review for the Labeling and Promotional materials etc. Good Regulatory Practices (GRP) - Prepare and review necessary standards (SOP's, Procedures etc) to facilitate the Regulatory functions, thereby implementing Global Regulatory Affairs policies (Regulatory Quality Systems), local regulations and acceptable Good Regulatory Practices. Support the RA manager for implementation of the quality system standards in the affiliate market maintaining the necessary documentation, licenses etc. including training. Regulatory Influence External Regulatory Environment Changes Support the RA Manager to keep updated with current local regulations and DRA organizational structure and potential changes that will impact the business environment, and communicate appropriately to involved or affected parties. Internal Affiliate Organization Learn and understand the local affiliate organization and functions. Provide support function to build functional partnership and credibility to maximize regulatory value Educate the affiliate the value that the regulatory function can significantly contribute to the business. Additional Responsibility (if applicable) Provide necessary regulatory support for locally performed clinical trials/GCT (i.e. Prepare and review report on the clinical Trial dossier for submission; CT material labeling, other licenses, etc)CLICK HERE TO VIEW APPLY