TEJAL SANJAY GAWADE

Experienced Regulatory Compliance Officer skilled in regulatory submissions, dossier preparation, audit-ready documentation, and cross-functional coordination to ensure compliance with global regulatory standards at Vicco Laboratories, Parel, Mumbai.

• Regulatory Liaison: Acted as the primary point of contact with regulatory authorities, ensuring 100% compliance, and achieving timely approval of submissions within defined deadlines.
• Cross-Functional Collaboration: Coordinated R&D, Quality Assurance, and Manufacturing teams to compile accurate documentation, reducing submission errors by 20%.
• Document Compliance Review: Assessed scientific and legal documents, ensuring adherence to regulatory requirements, and minimizing re-submission rates.
• Scientific Data Analysis: Collected, collated, and evaluated scientific data from multiple sources, supporting successful product registrations, and renewals.
• Regulatory Submissions: Prepared and submitted dossiers to global regulatory agencies, resolving 95% of authority queries within set timelines.
• Product Knowledge Management: Maintained in-depth knowledge of the product portfolio, ensuring accurate and up-to-date regulatory filings.
• Guideline Interpretation: Reviewed and communicated regulatory updates to stakeholders, enabling proactive compliance, and reducing audit observations by 15%.
• Regulatory Documentation Development: Authored justification reports and renewal documents, contributing to the approval of two new product licenses.
• Records Management: Maintained accurate and audit-ready regulatory records, supporting successful inspections with zero critical findings.
• Artwork compliance oversight: Reviewed product artwork to ensure consistency with dossiers and regulatory guidelines, achieving 100% compliance in packaging audits.

Regulatory Affairs Specialist with expertise in global compliance (EU, APAC, NA, LATAM), supplier coordination, and dossier preparation, ensuring 100% audit compliance and accelerated product approvals at FORTREA, Mumbai.

• Regulatory Compliance (Global): Ensured adherence to regional regulations across the EU (Cosmetic Regulations, REACH, CMR, BSE/TSE, 26 Fragrance Allergens, Animal Testing), APAC (Halal, Kosher, AICS, ADM-free, China REACH), and NA/LATAM (Canada Hotlist, California Prop 65, Residual Solvents, FDA, USP/NF, FSMA).
• Nutritional Regulations: Managed compliance for nutritional labeling and claims, including organic, gluten-free, and allergen statements, ensuring accuracy across multiple markets.
• Global Regulatory Coordination: Facilitated alignment of material qualifications with international standards, contributing to a 20% faster submission turnaround and seamless product registrations.
• Supplier & Stakeholder Communication: Led communication with 50+ global suppliers to secure compliance documentation and manage change requests, reducing supplier documentation turnaround time by 25%.
• Cross-Functional Collaboration: Partnered with Procurement, Analytical, Toxicology, Regulatory, and Manufacturing teams to conduct impact assessments and implementation strategies, ensuring zero delays in raw material approvals.
• China CSAR Compliance: Supported product registrations under new CSAR requirements on the NMPA platform, successfully resolving 95% of regulatory queries within timelines.
• Technical Documentation Review: Reviewed and validated Certificates of Analysis (COA), Material Safety Data Sheets (MSDS), and Technical Datasheets with 99% accuracy, strengthening audit readiness.