Regulatory Compliance Specialist
Current> Provided comprehensive regulatory support and guidance to ensure compliance with government regulations and policies in the pharmaceutical sector.> Spearheaded regulatory compliance efforts as a Procurement Subject Matter Expert, overseeing supplier & inventory management for the assigned region with an annual purchase budget upto $9.6M.> Managed processes for maintaining annual licenses, registrations, and listings in accordance with regulatory requirements.> Implemented regulatory compliance programs, resulting in a 20% decrease in compliance-related incidents.> Led Overseas regulatory submissions plan and regulatory due diligence, ensuring compliance with regional requirements.> Prepared and submitted regulatory reports, achieving a 30% increase in on-time regulatory filings.> Collaborated with cross-functional teams to align procurement practices with regulatory requirements, ensuring all processes and documentation met necessary standards of product approval & certifications.> Led the creation of audit files and assisted in preparing tender bids for international markets.> Delivered training programs on regulatory compliance and QMS, enhancing staff competency.> Acted as a single point of contact for external stakeholders' queries, resolving technical inquiries/requests, ensuring timely responses.> Played a critical role in maintaining regulatory compliance during the COVID-19 crisis by ensuring effective forecasting and strategic sourcing while complying with regulatory standards and guidelines.
