• Familiarity with US Federal Regulations and Guidance governing drug and device development (IND, IDE, NDA, ANDA, Orphan Drug designation, BLA, PMA) • Application of current CMC guidance (Drug Substance, Drug Product, Stability, Impurities in Drug Substance/Drug Product) and knowledge to ensure regulatory compliance for Investigational Products • Application of CMC guidance (Changes to an approved NDA or ANDA, EMA-Post authorization procedural advice, Health Canada Post Notice of Compliance Changes, BACPAC, Comparability Protocols etc) and knowledge to ensure regulatory compliance for Commercial Products • Understanding of QbD principles and related Guidances like Pharmaceutical Development (ICH Q8), Quality Risk Management (ICH Q9) and Pharmaceutical Quality Systems (ICH Q10), and also application of GxP (GMP, GCP, GLP) in pharmaceutical development • Expertise in Quality Assurance, Quality Control, Validation, Stability testing, procedures and regulations

Regulatory Affairs Specialist @ From November 2015 to Present (2 months) Regulatory Affairs Associate @ From April 2014 to November 2015 (1 year 8 months) Regulatory Affairs Specialist-CMC @ From November 2012 to April 2014 (1 year 6 months) Quality Control Specialist @ From August 2012 to November 2012 (4 months) Greater Boston AreaHepatitis Care Advisor @ From February 2010 to April 2010 (3 months) Territory Business Manager @ From February 2009 to January 2010 (1 year) Member Mission Safety Team @ From June 2008 to December 2008 (7 months) Mumbai Area, IndiaIndustrial Trainee-Intern @ From May 2007 to June 2007 (2 months) Mumbai Area, India

Masters, Regulatory Affairs for Drugs, Biologics and Medical Devices @ Northeastern University From 2010 to 2012 Bachelor in Pharmacy, Pharmacy @ Dr. B. N. College From 2004 to 2008 Hiral Gutka is skilled in: Team Leadership, Organizing, Detail Orientation, Documentation, Clinical Trial Management, Clinical Data Management, Data Entry, CTMS, CMC Regulatory Affairs, IND, Software Documentation, Regulatory Affairs, CMC, Regulatory Submissions, GMP, Validation, GLP