Dipal Patel Email & Phone Number

Toronto, Ontario, Canada

▪ Develop regulatory label text for new products or amend labels for existing products in accordance with Cosmetic regulations as well as NHP regulations.▪ Review and approve promotional material and various product labeling components to ensure compliance with applicable guidelines and regulations.▪ Support the development and implementation of SOPs for the regulation of marketing materials.▪ Accurately assess change controls to write the Change Control Form (CCF) and determine filing requirements.▪ Liaise with several departments including R&D, Global Marketing team, Quality, Supply Chain, and Legal to provide regulatory support to achieve high-quality submissions.▪ Liaise with a team of internal and external translators for designing language cover-ups (EU languages, Korean, Arabic, Traditional Chinese, Hungarian, etc.) for packaging and labeling components.

Ontario, Canada

▪ Perform analytical testing of pharmaceutical raw materials and finished products using dissolution, disintegration, HPLC, TLC, IR and UV spectroscopy.▪ Perform physical testing and wet chemistry as per validated methods (friability, hardness, particle size analysis, viscosity, loss on drying, deliverable volume, Karl Fischer titration, melting point).▪ Accurately document all tests/test materials/equipment used and results obtained in accordance with Good Documentation Practice.▪ Work in accordance with approved methods, SOPs, and GxPs while performing tests.

Vadodara, Gujarat, India

▪ Worked and assisted on varied regulatory affair assignments involving marketing authorization applications for parallel imported drug products and different amendments for Europe and UK markets.▪ Effectively documented requirements of labeling, storage, and packaging of imported products according to the guidelines of the targeted market.▪ Prepared and reviewed product information leaflets, label mockups, and artwork ensuring that quality standards are met, and submissions meet strict deadlines.▪ Prepared and submitted Label and Leaflet variations to EMEA and MHRA.▪ Submitted supporting documents and amended packaging/labeling components to MHRA in response to RFIs (requesting further information) in a timely manner.

Gujarat, India

Actively involved in performing toxicity study, pyrogen testing and bioassays according to the current analytical procedure/SOP and laboratory guidelines in an accurate and timely manner.Performed literature reviews to analyze, integrate, and summarize the most recently available authentic medical/drug information.

Ontario College Graduate Certificate, Pharmaceutical Regulatory Affairs & Quality Operations (Raqc)

Ontario College Graduate Certificate, Administration And Management

Master'S Degree, Pharmacology, Distinction

Bachelor'S Degree, Pharmacy, Distinction