Responsibilities: * Lead regulatory strategy development & implementation * Manage dossier preparation, compilation & submissions * Oversee drug regulatory affairs in Row & Emerging markets
Regulatory & Licensing Prepare and manage applications for WHO certification, manufacturing & wholesale licenses, renewals, FOSCOS, FDA, and other statutory approvals. Handle CBN export NOCs, biodiversity returns, and related compliance filings. Coordinate with FDA officials (domestic & overseas) during licensing, audits, and certifications. Maintain compliance with cGMP, pharmacopoeial & non-pharmacopoeial standards, and GS1 barcode implementation. Documentation & Dossiers Oversee dossier preparation, submission, and re-registrations for international and domestic markets. Prepare documentation for product registrations, government tenders, and patent projects. Review artwork, promotional materials, and agreements for regulatory compliance. Address MOH and client queries on regulatory submissions. Product & Portfolio Support Coordinate with plants for commercial batch scale-up and product registrations. Support development of new formulations, product finalization, and execution. Assist in veterinary, nutraceutical, and dental projects as well as new client/product portfolio development. Stakeholder Coordination Liaise with business development teams, clients, and vendors to obtain required documentation (DMF/BA/BE, CDP, etc.). Guide and train junior regulatory staff, ensuring timely and quality submissions. Support client visits and cross-functional projects across departments. Audit & Compliance Generate audit compliance reports and assist during plant visits and inspections. Ensure timely renewals and adherence to all regulatory requirements.
Responsibilities: * Lead regulatory strategy development & implementation * Manage dossier preparation, compilation & submissions * Oversee drug regulatory affairs in Row & Emerging markets
Responsibilities: * Develop product strategy & roadmap * Manage product lifecycle from ideation to retirement * Conceive new products & optimize existing ones * Collaborate with cross-functional teams on execution
Responsibilities: * Develop packaging solutions * Conceptualize design ideas * Deliver creative designs within deadlines * Collaborate with cross-functional teams on artwork creation * Create graphical designs using CDR/ Adobe software