Manushi.A. Shah

+1-908-***-**** • adxg32@r.postjobfree.com • https://www.linkedin.com/in/manushi-shah-16376017b Education

Master of Science

Long Island University, New York, United States Graduated: May 2023 Bachelor of Pharmacy

Nirma University, Ahmedabad, India Graduated: May 2019 Experience

Regulatory Affairs Intern December 2022 - January 2023 Bionpharma INC, Princeton, NJ

• Performed and monitored over 100 Drug listing on the FDA CDER website by comparing drug labels version and updating the warnings and precautions.

• Mediated a proper chain of custody for controlled documents submitted to the FDA.

• Maintained an archive database to ensure documentation accuracy of Drug listing to obtain FDA approval. Regulatory Affairs Intern June 2022 - August 2022

Astellas Gene Therapies, San Francisco, CA

• Drafted and completed 1 Transfer of Obligation document to inform the FDA about the Contract Research Organization (CRO).

• Created and composed 4 Cover letters for different regulatory submissions to ensure efficient submission routing and management.

• Responsible for generating safety reports also known as SUSAR.

• Responsible for cover letter of Form 1571 as well as for other submisison like transfer of oblogation and investigation update

• Managed and familiarized with Electronic Common Technical Document (eCTD), FDA, Docu Bridge, Statement of Investigator (Form FDA 1572) preclinical, and clinical guidance. Patent Analyst March 2021 - August 2021

Excelon IP, Ahmedabad, India

• Prepared and improved 10 reports on the patent search to determine the eligibility of the invention for patenting.

• Compiled and processed about 25 patent applications and claims for specific inventions after reviewing the entire invention and removing unnecessary data in patent landscape reports with the use of In Pass. Junior Quality Assurance Officer September 2019 - March 2020 Troikaa Pharmaceutical, Ahmedabad, India

• Endorsed in maintaining the training database which involved creating and assigning new users, groups, and curriculums; ensured all training records were completed; collaborated with management to ensure appropriate training was assigned to all departments.

• Trained 5 employees in gowning and aseptic practices for Grade B, C, and D cleanrooms. Academic Projects

Graduate Project- Prepared an Investigational New Drug Application December 2022 - December 2022

• Mock Submission of IND for Fictional rheumatic disease according to eCTD Format.

• Worked on five various modules- Administrative Information, Quality, Chemistry manufacturing and controls, non-clinical reports, and Tabular listing of all clinical studies. Warning Letters April 2022 - April 2022

• Issued a mock warning letter to the CEO of the company for violation of cGMP. Undergraduate Thesis - Prostate Cancer (Review) March 2019 - March 2019

• Genetic analysis on tumor origin, aiding prognosis, different therapies, for instance Abiraterone and enzalutamide giving on androgen deprivation and AR signaling inhibitors are quite effective. Skills/ Core Competencies

Technical Skills: Microsoft Office, Technical Writing, Report Preparation, Communication and Presentation skills. Personal Skills: Active listening, Analytical & Conceptual, Flexible, Organizational & Planning, Creative & Methodical, Team Leadership, Project/Case Planning, Attention to Detail, Problem Solving. Certification: US Food & Drugs: CDER SBIA.

• FDA Clinical Investigator Training Course.

• Clinical Pharmacology Considerations for Neonatal Studies Webinar.

• RAPS: Streamlining Conformity Assessment in Device Submissions: FDA's ASCA Program. Relevant Courses

Mechanics of preparing INDs NDAs, CMC Regulatory Affairs, FDA Regulation of OTC drugs, medical devices, Cosmetics, and Animal drugs, pharmaceutical labeling advertising and promotion, Regulatory Compliance/Enforcement.

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