Regulatory Compliance Affairs

SHWETA PRAJAPATI

Vancouver, British Columbia, V*V 2P8

Phone: 236-***-**** Email: *************@*****.*** Regulatory Affairs professional with a postgraduate diploma in Pharma Management, seeking to leverage expertise in regulatory compliance and RIMS implementation for organizational success. Strong ability to address queries, manage finances, and engage with health authorities for maintaining regulatory standards and facilitating product registrations.Fast learner with an ability to work independently without supervision and passionate to excel at any given work project.

Work Experience

Lead Consultant at GENPACT INDIA PVT. LTD, Mumbai

(February 2019 – September 2023)

o Regulatory Compliance Gap Analysis: Conducting comprehensive assessments to identify regulatory compliance gaps.

o Offering insightful observations and recommendations for rectifying compliance issues. o Multi-Market Gap Analysis: Executing gap analyses for diverse markets, including Russia, US, EU, Australia, Mexico, Lebanon, Serbia, and Georgia.

o Preparing and organizing data in alignment with company guidelines prior to gap analysis. o Coordinating with manufacturing plants to fulfill raw data requirements for analysis. o Data Enhancement and Migration Support: Assisting in data enrichment and seamless data migration. o RIMS Implementation and Management: Leading projects focused on the implementation and administration of Regulatory Information Management Systems (RIMS) such as PRISM, GRACE, and VEEVA. o Conducting rigorous quality checks to ensure the accuracy of enriched data. Regulatory Executive at VHB MEDI SCIENCES LIMITED, Mumbai

(November 2018 – January 2019)

o CTD Dossier Compilation for African Markets: Proficiently compiled dossiers in CTD format tailored for African countries, including Zimbabwe, Kenya, Tanzania, Zambia, Sudan, Ethiopia, Namibia, Uganda, and others. o Swiftly and effectively addressed queries associated with dossier submissions, ensuring a smooth registration process.

o Coordinated with Manufacturing Units to ensure the punctual procurement of necessary technical documentation and samples.

o Conducted meticulous verification of raw data, chromatograms, validation data, and batch manufacturing records to maintain data integrity and regulatory compliance. Regulatory Executive at RENA EXPORTS, Mumbai

(January 2016 – August 2018)

o Dossier Compilation for African Markets: Expertly compiled dossiers tailored for the specific needs of semi-regulated markets in East African and West African countries, including but not limited to Nigeria, Kenya, Tanzania, Zambia, Ivory Coast, Burkina Faso, Benin, and others. o Efficiently handled dossier queries to ensure successful product registration. o Collaborated closely with Manufacturing Units to ensure timely documentation and procure necessary samples. o Orchestrated the collection and arrangement of essential legal documents required for product registration. o Artwork Compliance Review: Conducted thorough reviews of artwork to ensure alignment with country-specific regulatory requirements.

o Performed meticulous verification of raw data, chromatograms, validation data, and batch manufacturing records to maintain data integrity and regulatory compliance. Regulatory Coordinator at Ipca Laboratories Limited, Mumbai

(August 2010 – December 2015)

o Registration Submissions Coordination: Orchestrated registration submissions for the CIS, Latin America, West Africa, East Africa, and Southeast Asia regions.

o Query Monitoring and Follow-up: Diligently tracked and followed up on registration queries to ensure prompt resolution.

o Financial Oversight: Oversaw registration-related payments and meticulously managed dossier submission fees. o R&D Sample Procurement: Procured samples to support Research and Development (R&D) initiatives. o Resolution of Market Complaints: Effectively addressed and resolved product-related complaints from the market.

o Health Authority Engagement: Coordinated and facilitated plant visits, audits, and inspections by Health Authorities to maintain compliance and regulatory standards. Regulatory Affairs Officer at AJANTA PHARMA LTD., Mumbai

(July 2009 - August 2010)

o DCG(I) Dossier Compilation: Skillfully compiled DCG(I) dossiers and took independent charge of DCG(I) requirements.

o Clinical Documentation Coordination: Collaborated effectively with Clinical Research Organizations to acquire necessary clinical documents.

o Successfully oversaw the compilation, dispatch, and sample coordination within the dossier management process. o Coordinated with the Quality Control department to ensure the accuracy and completeness of documents. o Rigorously verified raw data to ensure data integrity and compliance. Regulatory Affairs Officer at PELL TECH HEALTHCARE PVT LTD., Mumbai

(August 2007- June 2009)

o Assembled comprehensive dossiers compliant with EU-CTD, Iran CTD, Philippines, Tunisia, Bangladesh, and Pakistan requirements for semi-regulated markets.

o Developed Manufacturing Licenses and Loan Licenses specifically for bulk drug operations. o Material development for packaging.

o Created essential documentation for quality operations to ensure regulatory compliance. Educational Qualifications

Postgraduate Diploma in Regulatory Affairs for Drugs (API & Formulation) from Institute of Pharmaceutical Management (Mumbai)

August 2018 – May 2019

Postgraduate Diploma in Pharma Management, Garware Institute of Career Education and Development, Mumbai June 2007

Bachelor of Science (Chemistry), Mithibai College (Mumbai University) April 2001 - March 2006

H.S.C., Thakur College (Mumbai University)

February 2003

S.S.C., M.A. High School (Maharashtra State Board), Mumbai March 2001

Industrial Training at Group Sanofi-Aventis, Mumbai

(May 2007)

Completed a 12-week summer internship in various departments focusing on regulatory affairs and related tasks.

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