Sonali Jaiswal
Assistant Manager- Regulatory Affairs @Fmi Health
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WORK HISTORY
Assistant Manager- Regulatory Affairs @Fmi Health
Gurugram, IN
Regulatory Compliance & Import Management:Ensured adherence to Indian regulations for drugs (CDSCO), nutraceuticals and supplements (FSSAI), and cosmetics (CDSCO).Conducted FSSAI compliance checks for US-sourced nutraceutical products, aligning with Indian regulatory standards.Managed product registration and importation processes for the UAE-Middle East and India, including obtaining permits, licenses, and certifications.Liaised with regulatory authorities in India and the UAE to address queries and facilitate product registrations.E-Commerce Development & Content Management:Developed and managed e-commerce platforms for nutraceuticals and cosmetics, overseeing Shopify backend operations and international supplier integration.Spearheaded the creation of an e-commerce platform for high RDA nutraceuticals, coordinating with internal stakeholders and external vendors.Prepared and curated website content, including product pages, labeling, and regulatory compliance.Operational & Strategic Coordination:Developed and implemented standard operating procedures (SOPs) for product sourcing, storage, and handling to maintain product quality.Collaborated with the marketing team to create regulatory-compliant marketing materials and campaigns for healthcare practitioners.Participated in cross-functional meetings and strategic planning to provide regulatory insights and recommendations for business growth.Conducted market research and competitive analysis to identify trends, customer preferences, and opportunities for product innovation.
EDUCATION
Central Board of Secondary Education
Intermediate, Science
Noida Institute of Engineering & Technology
Bachelor of Pharmacy - BPharm, Pharmacy
ABOUT SONALI JAISWAL
Regulatory Affairs professional with experience supporting pharmaceutical, nutraceutical, & cosmetic products across India and GCC markets. My expertise spans regulatory submissions, CTD dossier development, clinical trial approvals, product registrations, labeling compliance, regulatory intelligence, and lifecycle management.Currently, I support regulatory operations for a portfolio of 550+ SKUs, driving compliance, market access, and post-approval activities while navigating evolving regulatory requirements across FSSAI, CDSCO, DHA, and MOHAP frameworks.Throughout my career, I have successfully managed CDSCO submissions, CTD dossier preparation, clinical trial and BA/BE regulatory activities, product registrations, labeling reviews, regulatory impact assessments, and cross-functional collaborations with QA, R&D, Clinical, Supply Chain, and Commercial teams.Key areas of expertise include:• Regulatory Submissions & Dossier Management (CTD/eCTD)• Product Registration & Market Access• CDSCO, FSSAI, DHA & MOHAP Compliance• Clinical Trial & BA/BE Regulatory Affairs• Regulatory Intelligence & Gap Assessment• Labeling, Claims & Artwork Compliance• Lifecycle Management & Post-Approval Changes• Import/Export Regulatory Compliance• Health Authority Coordination• Cross-Functional Stakeholder ManagementI am passionate about translating complex regulatory requirements into practical business strategies that enable compliant product launches, sustainable growth, and successful market access.With a strong foundation in pharmacy, clinical research, and regulatory affairs, I continue to expand my expertise in global regulatory frameworks, regulatory intelligence, and emerging healthcare regulations.
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