Everything in this universe has a specific goal and function to perform. Goals can be individual and organizational. A systematic approach is a key to achieving the desired goal. The health care industries have a common goal of providing solutions to help people live a better life with continuous advancements, adaptions, and improvements. Regulatory Affairs is one of the most responsible department that design the course of the health care industry to achieve their common goal while being in compliance with the requirements of different world health agencies. My interest in the field developed during my undergrad while taking the course “Pharmaceutical Policy, Law and Jurisprudence. My curiosity about the subject made me choose the Masters of Pharmacy (Drug Development and Regulatory Sciences) at NMIMS, Mumbai. I realized the depth of the subject when I started my internship at Macleods Pharmaceuticals, Mumbai. At Macleods, I learned about different markets, Regulated and non-regulated, Dossiers, submissions, market complaints, analytical method developments, and validation, the R&D department, and various other departments which functions together to run a company as a whole. There I got the opportunity to prepare and submit an ANDA (Abbreviated New Drug Application) for an anti-hyperlipidemic drug. This project gave me practical hands-on experience in how the regulatory department works. Eventually, the ANDA got approved by US FDA. I chose to further dive into the ocean of regulatory affairs and decided to pursue a second Master’s degree from the US in Regulatory Affairs to explore the US and EU regulations.I am aiming to build a strong and comprehensive career in Regulatory Affairs. Looking for a challenging opportunity in Regulatory Affairs that will help me and the organization to grow together.
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Regulatory And Quality SpecialistVycor Medical, Inc. May 2024 - PresentBoca Raton, Florida, Us -
Regulatory Affairs Specialist Ii, Capstone ProjectBd Jan 2024 - Mar 2024Franklin Lakes, New Jersey, UsGlobal Regulatory Submissions for Alaris.• Working on the development and execution of global regulatory strategies by collaborating closely with international regulatory associates to prepare submissions to register MMS (Medication Management Solution) devices worldwide (8 countries). • Driving international registrations according to the project plan for BD Alaris Systems• Addressing and resolving requests for additional information by acting as cross-functional support for global regulatory submissions.• Compiling and communicating Regulatory impact assessments, submission & and approval status worldwide to the Supply Chain to ensure regulatory compliance and business continuity.• Conducted gap analyses by reviewing technical files, IFUs, CE certificates, ISO 13485:2016 certificates, MDD MDR transition documents, Clinical Evaluation Reports, and Notified Body issued certificates for uniformity among regulatory submissions. • Prepared and reviewed Declaration of Conformity (regional and international) for BD Alaris Systems• Identify ways to improve the efficiency of the current work process and recommend them. -
Regulatory Affairs InternCresilon Jan 2023 - Jun 2023Brooklyn, New York, Us• Prepared regulatory strategy for Class III medical device (hemostat) covering USFDA and South Korea jurisdictions• Collaborated and brainstormed with other teams on predicate selection, indication and intended use.• Performed high-level risk analysis for products under development (hemostat)• Conducted literature survey for hemostat product under development• Prepared product profile, pager document, and assessment questionnaire (product development, design input, and output, design validation, for key opinion leaders (surgeons, physicians)• Assisted in preparing and maintaining medical device regulatory submissions, including US FDA 510 (k)'s, pre-sub meeting packages, de novo applications, IDEs.• Drafted COA, COO, and animal-free component declaration templates for existing and upcoming products.• Maintained up-to-date knowledge of international and domestic regulatory requirements using regulatory intelligence tools such as IHS Markit. • Collaborated and provided required deliverables to product development teams as the internal regulatory team member throughout the product lifecycle phases for current and upcoming products. Tasks included drafting, review, input, and approval of test protocols and reports, FMEAs (fish-bone), clinical trial protocol, and related documentation requiring RA input for product development teams• Performed artwork and label reviews for existing and upcoming products from a regulatory perspective• Conducted regulatory assessments concerning manufacturing changes.• Reviewed product promotional material. -
Pharmacist And Regulatory Compliance-Business OwnerCity Care Pharmacy Sep 2016 - Dec 2021• Achieved sales of INR 100 million (US $ 5.8 million in PPP index) in span of 5 years. • Maintaining inventory, stock procurement, performing sales forecasting • Maintaining profit loss accounts, expiry returns, tax filing• Maintaining food and drug licenses and renewals• Employee training• Maintaining relationships with suppliers, customers, and local government bodies for smooth functioning of the business • Wholesale third-party manufacturing and distribution.
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Regulatory Affairs InternMacleods Pharmaceuticals Ltd. Jun 2015 - Dec 2015• Successfully prepared and submitted complete ANDA for an antihyperlipidemic drug • Assisted in auditing the manufacturing and R&D center for drug development in compliance with US-FDA.• Handled FDA queries on regulatory submissions.• Prepared dossiers for drug product approval for different countries like Nigeria, Ghana, Nepal, Russia, Brazil, DR Congo, and other African and Middle Eastern countries.• Preparation and compliance of the artwork and label.• Conducting Installation Qualification, Operational Qualification, and Performance Qualification of LC-MS, HPLC, Dissolution Apparatus, and GC apparatus.
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LecturerGurukul Classes Jan 2011 - Dec 2015Lecturer for high school students in Chemistry and Biology.Chemistry lecturer for Bachelor of Science (Major-Organic Chemistry)
Shailesh P. Education Details
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Northeastern UniversityRegulatory Affairs -
Narsee Monjee Institute Of Management StudiesDrug Development And Regulatory Sciences
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University Of MumbaiPharmacy
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Changu Kana Thakur Institute Of Management Studies And ResearchScience
Frequently Asked Questions about Shailesh P.
What company does Shailesh P. work for?
Shailesh P. works for Vycor Medical, Inc.
What is Shailesh P.'s role at the current company?
Shailesh P.'s current role is Medical Device Regulatory Affairs.
What schools did Shailesh P. attend?
Shailesh P. attended Northeastern University, Narsee Monjee Institute Of Management Studies, University Of Mumbai, Changu Kana Thakur Institute Of Management Studies And Research.
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