Principal task and responsibilities : • Submission of product dossiers for registration, in various countries including India as per the agreement with customers or as per the internal plan • Submission of product dossiers for re-registration in various countries • Submission of Clinical trial applications, variation applications in various countries; import/export permits, NOCs for BE studies • Provide regulatory inputs in special projects, during development of product, variation submissions and commercial supplies as applicable. • Gap analysis of product dossiers in existing markets for up gradation and submission of same in other markets. Develop regulatory defence mechanisms where needed. • Serve as the key contact for regulatory agency, notified body and business partners. • Develop and implement effective regulatory strategies to bring products to market and assessment of the probability of regulatory success for post-approval changes/commitments. • Promote the development of a facility–wide understanding of the key elements related to quality system and regulatory compliance requirements. • As a member of the senior management team, provide sound advice and guidance regarding the impact of regulatory and quality issues on overall corporate strategy and operations. • Identify ways to continuously improve quality and compliance with regulations and company standards, policies and procedures. • Review of technical/investigation reports, summaries for adherence to regulatory guidelines and to provide guidance to cross functional technical teams for the requirement and content of regulatory documentation. • Evaluation of regulatory non-compliances and providing short term and long term mitigation measures • Skill-development and coaching of regulatory and cross functional teams. • Review and approval of investigation reports, deviations, change controls, CAPA for market complaints and other operational documents. Evaluation of technical agreements, due deligence of in-licensed dossiers, as needed. • Steer regulatory audits and active participation in responding to inspectional observations, identification of CAPA, compliance enhancement plans and sustained compliance with GMP requirements • Suggest resolution of post approval operational issues during manufacture of commercial batches and collaborate with multiple business partners as needed.
