Parveen Jain, RAC (Drugs and Devices)
Senior Director, Quality and Regulatory Affairs, Asia Pacific @ Fresenius Medical Care
About
Regulatory Affairs RAC certified in both drugs and device and a professional with in-depth knowledge, understanding, and experience in Pharmaceutical, Biological, Biosimilars, Medical devices, and OTC. Have started my journey with Syngene (Biocon Group company), followed by Eli Lilly, Reckitt Benckiser, and now with Fresenius Medical Care. Having a proven track record of completing complex regulatory projects, and gaining regulatory approvals in Asia Pacific countries.
India
Gurgaon
Hospital & Health Care
Regulatory Affairs, FDA, Clinical Trials, Regulatory Submissions, GCP, CTD, Regulatory Guidelines, Drug Safety, CMC Regulatory Affairs, Clinical Development, Regulatory Strategy Development, Regulatory Requirements, Clinical Research, Pharmaceutics, ICH-GCP, Good Clinical Practice (GCP), Standard Operating Procedure (SOP), Good Manufacturing Practice (GMP)
Experience
Senior Director, Quality and Regulatory Affairs, Asia Pacific
Fresenius Medical Care
Gurugram, Haryana, India
Responsible for Quality and Regulatory Affairs, Asia Pacific, Fresenius Medical Care
Director- Transformational Lead, Quality and Regulatory Affairs, Asia Pacific
Fresenius Medical Care
Gurugram, Haryana, India
Short Term Assignment as Director and Transformational Lead for Asia Pacific- Quality and Regulatory Affairs.
Head- Regulatory Affairs, Quality and Government Affairs, South Asia
Fresenius Medical Care
Gurgaon, India
Responsible for Regulatory, Quality and Government Affairs, South Asia
Regional Regulatory Manager- South Asia
Reckitt
India
Senior Manager Regulatory Affairs
Eli Lilly and Company
Gurgaon, India
Manager- Regulatory Affairs
Eli Lilly and Company
Gurgaon, India
Senior Regulatory Affairs Associate
Eli Lilly and Company
Gurgaon, India
Senior Regulatory Associate
Syngene International Limited
Bangalore
Regulatory Associate
Syngene International Limited
1. Compilation and review of dossiers for Clinical trials approval including NCE/NBE study for submission to Indian regulatory authority. 2. Author for high quality CMC documentation for Clinical trials approval. 3. Review and advice clients on CTA applications, BA/BE study dossier, Import License and Export NOC applications. 4. Communication with regulatory authorities. 5. Support BD team for regulatory advice to clients. 6. Process of incoming SAE reports and preparation of Sch Y(App XI)/CIOMS report. 7. Prepare and review of SOPs for Regulatory Affairs and Clinical Development department.
Faculty in the Department of Pharmacy Practice
National Institute of Pharmaceutical Education and Research
Education
National Institute of Pharmaceutical Education and Research
Department of Pharmacy Practice
Kurukshetra University
Pharmacy
Parveen Jain, RAC (Drugs and Devices)'s Contact Information
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