Sweta V Kiran

[email protected] • 9482102827

PROFESSIONAL SUMMARY

Regulatory Affairs Professional with over 5 years of expertise in compliance management, regulatory submissions, and documentation control within FDA and EMA-regulated industries. Certified in Regulatory Affairs (RAC), I have streamlined submission processes to reduce approval times by 20%, ensuring timely market access and strict adherence to evolving regulatory standards. Proficient in cross-functional project coordination and information governance, I excel at managing complex regulatory projects that enhance organizational compliance and operational efficiency. I am eager to leverage my regulatory knowledge, certifications, and project management skills to drive your team’s regulatory excellence and business success.

WORK EXPERIENCE

Senior Analyst-Corporate Records & Information Management
10/2024 - Present
Kenvue Pvt Ltd , Bangalore, Karnataka
• Led cross-regional coordination with 20+ stakeholders across APAC, streamlining document and records operations to boost process efficiency by 15% and enhance service delivery timelines
• Managed vendor performance and negotiated contract terms, achieving a 10% reduction in record-transfer costs by eliminating unnecessary POs and optimizing storage and scanning expenses
• Directed an APAC-wide records destruction and compliance project, ensuring 100% adherence to legal, regulatory, and corporate governance standards, mitigating compliance risks
• Oversaw approval processes for legal holds, supporting risk mitigation efforts for audits, investigations, and business continuity, reducing potential legal exposure
• Provided project management leadership for multi-department initiatives, standardizing workflows and increasing operational efficiency across the region by 20%
Executive-Regulatory Affairs
01/2024 - 10/2024
Clinchoice Pvt Ltd , Bangalore, Karnataka
• Led the end-to-end CMC life-cycle management and regulatory submissions for Johnson & Johnson, Kenvue, and Janssen products across EMA, APAC, MENA, and LATAM regions, ensuring 100% compliance with global regulatory standards
• Executed over 50 regulatory submissions annually, achieving timely approvals and renewals by delivering accurate documentation and coordinating cross-functional teams
• Collaborated with internal stakeholders and external partners to streamline global submission processes, reducing submission cycle time by 15% and enhancing regulatory compliance
• Managed post-approval activities including xEVMPD and IDMP submissions for EMA, tracking variations and addressing health authority correspondence promptly to maintain uninterrupted product market access
Junior Regulatory Affairs Associate
02/2022 - 12/2023
Clinchoice Pvt Ltd , Bangalore, Karnataka
• Led the preparation and review of over 100 regulatory submissions, including product renewals, variations, and PSURs for Johnson & Johnson, Kenvue, and Janssen products across EMA, APAC, MENA, and LATAM regions, ensuring 100% compliance with health authority guidelines
• Executed a critical data migration project for Genpact, successfully transferring regulatory data using Cunesoft-RIMS with zero data loss and improved submission tracking efficiency by 20%
• Collaborated closely with business users to review and validate data entries in the RIMS application, reducing submission errors by 15% and accelerating approval timelines
• Managed cross-functional communication with clients and health authorities to resolve queries promptly, enhancing client satisfaction and maintaining up-to-date submission status in Veeva Vault and Cunesoft systems
Regulatory Affairs Consultant
10/2020 - 10/2021
Syngene International Ltd , Bangalore, Karnataka
• Led comprehensive regulatory research and analysis for pharmaceutical application submissions, ensuring 100% compliance with current laws and regulations, resulting in timely approvals by the Drug Control Department
• Spearheaded client interviews and synthesized critical insights into detailed reports, enhancing the accuracy and quality of regulatory documentation
• Managed end-to-end DCGI submissions via Sugam portal and hard copy, including import & test licenses, marketing authorizations, and loan licenses, accelerating approval timelines by 15%
• Coordinated post-approval activities such as legalization of documents and query resolution, improving client satisfaction and reducing follow-up cycles by 20%

EDUCATION

M-Pharm in Pharmaceutics
09/2018 - 05/2020
Rajiv Gandhi University of Health Sciences , Bangalore, Karnataka GPA: 3.8
B-Pharm in Pharmacy
05/2014 - 05/2018
Rajiv Gandhi University of Health Sciences , Bangalore, Karnataka GPA: 3.5

SKILLS

Technical Skills: Regulatory Compliance, Regulatory Documentation, Records Management, Information Governance, Document Control, Version Control, Metadata Management, Quality Assurance, Basic Project Management, Stakeholder Coordination
Soft Skills: Communication, Analytical Thinking, Problem Solving, Attention to Detail, Time Management, Cross-Functional Collaboration, Process Improvement
Tools: SharePoint, Veeva Vault, Microsoft Office Suite
Other: Corporate Records Management, Information Management, Industry Knowledge - Regulatory Affairs

CERTIFICATIONS

PG-Diploma in Drug Regulatory Affairs
08/2023
NCK Pharma

Similar Resumes You May Like

Akanksha Hire

Hemanath

MANJULA D

FINANCE

RITHIKA S

Intern

MAHALAKSHMI R

HR EXECUTIVE