Sarthak Kotecha Email & Phone Number

Nagpur, Mh, In

Paris, France, Fr

• Authored eCTD Module 3 documents, emphasizing analytical procedures and validation documents, included in phase III clinical trial final dossier of COVID-19 vaccine.• Authored Module 2 documents for Investigational New Drug Application.• Created BLA and EUA compliant eCTD Module 1, 2 & 3 CMC document templates in Veeva.• Communicated cross-functionally with global regulatory associates to determine goals for CMC and meet the set deliverables.• Used Veeva Vault to create product technical file packages for global product compliance certifications of company products.• Prepared and maintained document inventory for core dossier preparation in collaboration with local and international R&D and publishing teams.• Worked cross-functionally for aiding in regulatory operations tasks for Veeva Rim metadata evaluation and management.• Supported the Global RA team in tracking and updating project plans and overall support on various cross-functional projects. • Authored quality documentation concerning investigational medicinal products in clinical trials to be compliant with EMA guidelines. • Integral part of the Global RA team tasked with preparing and compiling eCTD final dossier for multiple products to comply with EU regulations.

Princeton, New Jersey, Us

• Worked on change control process, dealing with cross-functional teams to perform the functions of drafting, updating, maintaining, and compiling SOPs for the Boston Integra site. •Ensured that the procedures followed at the company comply with relevant ISO, ASTM, FDA, and EU regulations and standards.• Acted as site coordinator to perform gap assessment of the company products to comply with the EU MDR transition and remediation plan.• Participated in internal and external site audits and worked on numerous NCs and CAPAs to ensure continuous and meticulous improvement in quality compliance, Good Documentation Practice (GDP), and Good Manufacturing Practices (GMP).• Reviewed and approved manufacturing batch records and QC testing data before releasing the company's finished batch of devices.• Author and reviewed STeD files to assure the product follows the new EU Medical Device Regulation. • Reviewed and analyzed the US and various international markets' labeling requirements to ensure that the product labels meet the country's regulations.

Princeton, New Jersey, Us

• Reviewed the regulations governing the use of Biologics and Pharmaceutical products in Special Populations such as pediatrics, geriatrics, pregnant women, patients with hepatic or renal impairment, and genetic disorders.• Prepared a comparative analysis of regulatory and clinical trial requirements for special populations in the US, EU, and Canada using ICH guidelines, FDA regulations, and guidance, EU directives.• Collaborated with the Sponsor for devising a strategy, as per New Drug Application (NDA) requirements, to obtain breakthrough therapy designation for the product to obtain expedited approval.• Evaluated Investigator’s Brochures, Informed Consent Forms, IRB requirements, and Periodic Adverse Event Reports (PADERs).

Burlington, Massachusetts, Us

• Supervised and managed the content incorporated in the research documents on the topic “Manganese Accumulation in the Brain due to Alcohol Consumption and Exacerbation of Manganese-Induced Neurotoxicity.”• Performed editing, proofreading, and revision of audit reports, validation reports, and standard operating procedures.

Boston, Ma, Us

• Responsible for creating, editing, posting, updating, and occasionally cleaning up outdated content on the Northeastern University's Campus Recreation website. • Oversaw the blogs and content presented on Campus Recreation and Intramurals websites.

Mumbai, Maharashtra, In

• Assisted in obtaining the marketing approval submissions of herbal pellets in the Indian market.• Participated in cross-functional teams by working closely with product development, clinical, and quality functions.• Analyzed stability study data and checked their compliance with Quality ICH guidelines.• Studied SOPs and gained hands-on experience in using equipment such as High-Performance Liquid Chromatography and Gas Chromatography. Performed QC tests using this equipment and documented test results as per FDA standards.

Master Of Science - Ms, Regulatory Affairs For Drugs, Biologics And Medical Devices

Master Of Business Administration - Mba, Health Care Administration/Management

Bachelor Of Pharmacy (B.Pharm.), Pharmacy, Pharmaceutical Sciences, And Administration