Priyanka Sura

About Priyanka Sura

Business-minded, results oriented Board-Certified Regulatory Affairs Leader with extensive experience in regulatory affairs and product stewardship strategies across industries. Adept at leveraging technical skills to make strong contributions across the value chain. Cross- functional collaboration with with Sales, Marketing, Customer Service, Legal, Research & Development and Supply Chain leaders to meet business objectives, drive development and commercialization.• Specialized in Regulatory Affairs, Product Safety, Regulatory toxicology, Product Stewardship & Post Market Surveillance/ Pharmacovigilance.• Experienced in managing compliance obligations of Global and Domestic Regulatory Guidelines: EU-REACH, RoHs; US FDA- API, Excipients, Food Contact Substances, GRAS Notifications, Cosmetic & OTC; USEPA- TSCA, PMN; CA-Proposition-65, Green Chemistry, OSHA HAZCOM; Korea-REACH; Canada-DSL; Conflict Minerals; Retailers Sustainable Chemistry Policy etc.• Working knowledge of QA/QC Procedures- GCPs, GLPs, cGMPs, ISO, & OECD.• Effective management of safety related issues with stakeholders such as customers, consumers, legal counsel, and regulatory agencies.• Member in Industry Trade Associations.• Working knowledge of Trade compliance- Tariffs (HTS) & Free Trade agreements• External peer reviewer for US EPA Chemical Safety Panel (EPA P3 Phase I) and SBIR• Scientific Advisory Committee on Alternative Toxicological Methods (SACATM) member (20••••24): https://ntp.niehs.nih.gov/ntp/about_ntp/sacatm/2020/september/rostersacatm20••••03_508.pdf

Experience

1. Senior Occupational Toxicologist, Environmental & Occupational Toxicology

   Gilead Sciences

   Jul 2022 — Present · Foster City, CA, US

   Member of Environmental and Occupational Toxicology (EOT)/ Nonclinical Safety & Pathobiology function at Gilead. The EOT group provides expert toxicological documentation for occupational health categorizations / occupational exposure limits, permitted / acceptable daily exposures for cleaning validation, environmental risk assessments, pharmaceutical impurity assessments (including mutagenic / carcinogenic impurities), QSAR assessments of impurities for ICH M7 compliance, deviations, leachables and extractables and excipients. EOT group at Gilead is also responsible for monitoring and reviewing toxicology tests including ecotoxicology, mutagenicity testing for impurities, and worker safety testing.

Education

• Kerala Agricultural University

  BVSc & AH (DVM equivalent), Veterinary Medicine

  1997 — 2003

• University of Connecticut

  MS, Pharmacology/Toxicology

  2006 — 2008

• The Ohio State University

  MS, Veterinary Epidemiology/Food Safety

  2004 — 2007

Skills

• Glp
• Life Sciences
• Pharmacology
• Cell Culture
• Good Laboratory Practice (Glp)
• Pcr
• Regulatory Affairs
• Lifesciences
• Eh&S Compliance
• Research
• Reverse Transcription Polymerase Chain Reaction (Rt-Pcr)
• Ghs
• Sap-Msds Creation
• Elisa
• Molecular Biology
• Reach
• USA-Fda- Food Contact and Medical Devices
• Chemistry
• Rt-Pcr
• Western Blotting
• Toxicology
• Immunohistochemistry
• Veterinary Medicine
• Polymerase Chain Reaction (Pcr)
• Eu Food Contact-Efsa, Bfr and Warenwet
• Data Mining
• In Vivo
• Science
• Biochemistry