Aparna Prabhune

Oversee complete regulatory activities, from dossier preparation to approvals, variations, licences, renewals, clinical trial submissions etc for pharmaceutical (IND/NDA/ SND/ FDC), biological, cosmetic, nutraceutical and device categories. Handle state‑level filings (manufacturing licence, plan approval, GMP certification and Wholesale Licence) RnD Facility DSIR recognition Handled Pollution control permissions, factory licences and ISO quality certifications. Attending SEC meetings for project deliberations Product Life Cycle maintenance Maintaining close communication with Regulatory Authorities Develop plans for new product approvals, guide evaluations and launches. Assess post‑approval changes Represent the organisation in expert forums. Prepare SOPs, Stay updated on new requirements Check labels and promotional material Manage safety reporting and Work with multiple teams to finish projects on time

Lead Regulatory, Pharmacovigilance and Medical Information functions across the India market

Directed regulatory operations for the India market with leadership of a five‑member team

Completed regulatory dossiers within required timelines for registrations, approvals, variations, licenses, renewals, and clinical trial submissions for pharmaceuticals, vaccines, biologicals, cosmetics, nutraceuticals, and devices via SUGAM and CDSCO. Maintained strong coordination with regulatory authorities and developed strategies for new product approvals and launches. Handled post‑approval evaluations for vaccines and r‑DNA products, took part in committee meetings, and presented applications. Led product life cycle planning, prepared SOPs, monitored updated regulations, and assessed their impact. Reviewed packaging, labelling, and promotional content for compliance and managed safety‑related reporting. Collaborated across teams to support smooth processes and timely delivery of projects.

Led end‑to‑end regulatory work including product registrations, marketing approvals, renewals, import permissions, trial submissions and variation assessments for multiple therapeutic areas and product categories across South Asia. Managed regulatory reviews, prepared quality documentation Ensured compliant labels and promotional materials Built strong regulatory agency relationships Maintained key safety files, supported safety reporting Provided leadership within regulatory and pharmacovigilance teams

Managing registration applications for finished formulations across CIS, African, American and Asian regions, including countries such as Kazakhstan, Russia, Burkina Faso, Cameroon, Ethiopia, Ghana, Kenya, Nigeria, Haiti, Jamaica, Venezuela, Bangladesh, Myanmar, Nepal and Sri Lanka. Handling regulatory submissions for tender processes in Benin, Cameroon, East Caribbean, Ghana and St. Lucia. Reviewing labels and packaging to ensure regulatory compliance.

Coordinating registration applications for finished formulations across African, American, and Asian regions, including Burkina Faso, Burundi, Cameroon, Dominican Republic, Ethiopia, Ghana, Ivory Coast, Kenya, Mali, Nigeria, Venezuela, Myanmar, and Sri Lanka. Handling tender filings in Benin, Congo, Cameroon, Ghana, Mali, Sudan, Senegal, Rwanda, Zimbabwe, Zambia, and Canada. Managing product life cycle. Handling Ghana export orders Ensuring label and packaging compliance Maintaining strong cross-team collaboration.