SUMMARY

Results focused and detail oriented professional with experience working in pharmaceutical companies. Analytical with strong background in understanding of FDA, ICH and other regulatory CMC requirements through all phases of development, post-approval, and life-cycle of the product. Proven ability to effectively manage time, contribute effectively to project teams, achieve deadlines and collaborate with colleagues.

CORE COMPETENCIES

Regulatory Submissions Regulatory Strategy

Critical Thinking Written Communication

Oral Communication Organizational Skills

EDUCATION

Northeastern University, Boston, MA December 2017

Master of Science in Drug Regulatory Affairs

Focused coursework: Regulatory guidelines & submissions (Drug, Biologics & Medical Device)

CGPA:3.8

University of Mumbai, Mumbai, India June 2011

Bachelor of Pharmacy

ACADEMIC PROJECTS

Prepared cover letter for formal meeting request with the FDA, IND amendments, and NDA supplements.

Prepared a fast track designation request to the FDA.

Identified, strategized and drafted a regulatory pathway for the medical device.

Prepared an Informed Consent Form for a study protocol using 21 CFR 50.

EXPERIENCE

MARION BIOTECH, Mumbai, India August 2013 – October 2015

Senior Regulatory Affairs Executive

Compiled dossiers for ASEAN countries (CTD format) like Vietnam, Cambodia & Philippines.

Compiled dossiers for CIS countries like Kazakhstan, Turkmenistan, Uzbekistan, Kyrgyzstan,

& Azerbaijan

Compiled dossiers for African countries like Zambia, Kenya, Nigeria, Mali, Niger, Burkina Faso,

Benin, and Togo.

Addressed and responded to questions from regulatory agencies.

Maintained records for renewals of marketing authorization.

Post-marketing authorization commitments.

Arranged samples & developed packing material as per registration requirements.

HEALTHY LIFE PHARMA, Mumbai, India November 2011 – August 2013

Regulatory Affairs Executive

Coordinated and provided support for preparation and dispatch of quality regulatory documents,

dossiers: CTD format in agreed timeframes.

Evaluated key issues for discussion with health authority experts to clarify questions.

Co-ordinated with the Quality Assurance department to update analytical method validation, process validation, and batch manufacturing records.

Requested data from the manufacturing site and submitted the updated version of the dossier to

competent authorities.