Shachi Virlley
Regulatory Affairs Associate @Regulatory Wisdom
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WORK HISTORY
Regulatory Affairs Associate @Regulatory Wisdom
Delhi, IN
As a Scientific and Regulatory Associate at Regulatory Wisdom, I played a pivotal role in ensuring regulatory compliance and facilitating the registration and approval of nutraceutical products. Leveraging my expertise in EAP regulations of ASEAN, LATAM, and European countries, I successfully prepared and submitted comprehensive dossiers for regulatory authorities. Additionally, I contributed to the development and preparation of Periodic Safety Update Reports (PSUR).Responsibilities- Conducted thorough research and analysis of EAP regulations in ASEAN, LATAM, and European countries, ensuring compliance with regional requirements- Prepared and compiled comprehensive dossiers for submission to regulatory authorities, encompassing scientific data, safety information, and relevant documentation- Collaborated closely with cross-functional teams, including R&D, Quality Assurance, and Clinical Development, to gather necessary data and documentation for regulatory submissions- Ensured accuracy, completeness, and adherence to regulatory guidelines in all dossier components- Contributed to the preparation of Periodic Safety Update Reports (PSUR), conducting in-depth analysis of safety and efficacy data- Coordinated and facilitated communication with internal stakeholders and regulatory authorities, addressing queries and resolving regulatory issues- Stayed updated with evolving regulatory guidelines, requirements, and industry trends, providing insights and recommendations to internal teams- Maintained meticulous attention to detail and critical analysis skills to ensure the accuracy and compliance of regulatory submissions.
EDUCATION
RAKSHPAL BAHADUR COLLEGE OF PHARMACY, BAREILLY
Bachelor of Pharmacy - BPharm
ISF college of Pharmacy, Moga
M. Pharmacy
ABOUT SHACHI VIRLLEY
Welcome to my LinkedIn profile! I am a highly motivated and experienced pharmaceutical professional with a strong background in regulatory affairs, quality assurance, and compliance. I specialize in navigating the regulatory landscapes of ASEAN, LATAM, and European countries, ensuring compliance with regional requirements. My expertise includes preparing dossiers for nutraceutical products and contributing to the development of Periodic Safety Update Reports (PSUR). I have a keen attention to detail, critical thinking skills, and problem-solving abilities. Collaborating closely with cross-functional teams, including R&D, Quality Assurance, and Clinical Development, I have ensured the accurate and timely submission of regulatory documents. I have maintained a strong understanding of evolving regulatory guidelines and requirements, providing guidance and support to internal stakeholders.My educational background, coupled with practical experience, has honed my attention to detail, critical thinking abilities, and problem-solving skills. I am dedicated to upholding the highest quality standards and fostering regulatory compliance throughout the product lifecycle.
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