Abhishek Chanagouda Patil

Accomplished regulatory professional with over a decade of experience in API regulatory aspects (ASMF/DMF), market requirements, and problem-solving. Strong leadership skills, team building, and excel in fostering excellent customer relations. Proficient in decision-making to drive positive impact on company success.

• Rewarded STAR performer in one of my previous organizations for my exceptional dedication and accuracy in work.
• Completed MS-CIT (an Information Technology literacy course).
• Gave a seminar on ‘Protection and De-protection of Functional groups.’
• Certified for best article in NAVRAS (a college magazine).

• Strong understanding of scientific principles with expertise in address
• Comprehensive knowledge of regulatory requirements across various global health authorities, including USFDA, EDQM, Health Canada, PMDA, CDE, MFDS, TGA, MEDSAFE, Brazil, and South Korea.
• Adaptable and resilient, with proven ability to perform under pressure while maintaining a high standard of work quality.
• Skilled in analyzing and responding swiftly to agency queries, creating actionable plans to meet deadlines for time-sensitive deficiencies.
• Proficient in prioritizing tasks based on business requirements, ensuring alignment with managerial objectives.
• Demonstrates consistency and dedication to delivering high-quality work within established timelines.
• Enjoys tackling anticipated deficiencies, developing proactive mitigation strategies aligned with business needs.
• Innovates by identifying new and effective methods to achieve targets.

• Drafted scientific CMC (Chemistry, Manufacturing, and Controls) sections for regulatory submissions.
• Reviewed documents from cross-functional teams for RA (Regulatory Affairs) compliance and provided scientific inputs.
• Edited and updated documents for amendments and deficiency responses.
• Strategized solutions for handling deficiencies from health authorities and customers; worked proactively on anticipated deficiencies.
• Extracted and summarized CMC sections based on cross-functional team reports.
• Drafted and shared customer notifications (before and after change implementations).
• Delivered comprehensive training on Nitrosamines impurity, NDSRI, and control strategies at sites and global levels.
• Expertise in mutagenic impurity risk identification, spike/purge studies, and designing control strategies.
• Communicated effectively with customers, addressing regulatory queries to achieve mutually beneficial outcomes.
• Collaborated with cross-functional teams to ensure timely completion of regulatory tasks.
• Conducted training sessions on latest regulatory trends and developments.
• Ensured compliance and approval of regulatory documents from cross-functional teams.
• Provided accurate regulatory feedback for documents reviewed (e.g., stability studies, synthesis routes, impurity details).
• Managed post-approval changes for API in various regulatory frameworks (e.g., USDMF, EUASMF, CEP, Health Canada).
• Prepared oDMF documents and supported customer registrations in regulated markets.
• Oversaw change controls, supplier notifications, and investigations, offering regulatory insights.
• Supported cross-functional teams for health authority inspection readiness.

• Marketing Authorization Procedures in the European Union
• Assessment And Control of Mutagenic Impurities in Drug Substance
• Nitrosamine Impurities in Drug Substances and Drug Products
• RTR due Lack of Justification of Impurity Limits in API
• Regulatory Requirements in Various Markets for registration of DMF

• 9762480469
• 9588669252

• Father's Name: Chanagouda Guruling Patil
• Date of Birth: 08/28/91
• Gender: Male
• Nationality: Indian
• Marital Status: Married

Surfing the Internet: Proficient in researching and analyzing information online to stay updated on industry trends, gather insights, and enhance knowledge. Adept at navigating diverse digital platforms and leveraging online resources for problem-solving and innovation.

Playing Chess: Strategic thinker with a keen ability to plan and anticipate outcomes. Enjoys challenges that require critical thinking, concentration, and problem-solving skills to achieve goals in competitive environments.

Playing Cricket: Team player with experience in collaboration, communication, and leadership. Committed to achieving objectives through discipline, coordination, and determination, while fostering a spirit of sportsmanship.