Sandeep Patel

I am writing to express my interest in the Regulatory affairs/Quality assurance Manager position at your organization with 12 years of pharmaceutical experience, including 6 years in Regulatory Affairs (Regulated Markets EU/UK, Canada, Australia and US) and 6 years in Quality Assurance. Presently I am worked as Sr. executive in Regulatory affairs and business continuity department at Sun Pharmaceuticals Industries limited - Vadodara, where I have developed strong expertise in the new product/ANDA dossier compilation and submission along with post approval product lifecycle management for regulated markets, which is align closely with the requirements of this role. In my previous role quality assurance Executive at Aurobindo Pharma and Zydus Cadila Healthcare, I successfully handled quality management system and Quality GMP audits. This experience honed my ability to quality skill, and I am eager to bring this same dedication and innovation to your company.

Sun Pharmaceutical Industries Ltd. Vadodara, India Department: Regulatory Affairs & Business Continuity Designation: Sr. Executive May 2021 – Present

 ▪ Prepare, review, and compile CTD/eCTD dossiers (Modules 1–5) for US ANDA, Canada ANDS, and EU/UK MAA (CP, DCP, RUP and National) submissions for Human Pharmaceutical Product.

 ▪ Manage regulatory submissions for solid oral dosage forms (IR, CR, SR, and complex formulations) and sterile dosage forms (injectables/parenterals, peptide products, drug–device combinations, terminally sterilized, aseptically processed, and lyophilized products).

 ▪ Coordinate with formulation development, analytical, and manufacturing teams to gather and verify data required for regulatory filings. ▪ Review and ensure accuracy and compliance of CMC documentation, batch records, stability data, and specifications in line with ICH and regional guidelines.

 ▪ Prepare and submit responses to health authority queries and deficiency letters US (IR, CRL), EMA, MHRA (day 70, D105, D145 responses) Canada (clarification request, NOD, NON) within defined timelines. 

 ▪ Manage post‑approval lifecycle changes including variations, supplements, renewals and ensuring ongoing regulatory compliance with uninterrupted supply of marketed products. 

▪ To evaluate change controls for US and OAM markets and provide a change category as per global regulations, guidelines, and policies. 

▪ To review variations in track-wise system and timely filing API, DMF, and CEP changes for implementation at the DF site for business continuity.

 ▪ To support new product launches by providing submission details and commitment from the agency.

 ▪ To review the RFC (rolling forecast) and priorities changes as per the supply impact.

 ▪ To prepare applications for Form 29, Form 25, Form 28, Export NOC, WHO GMP and Plant layout approval forms from the state FDA. 

▪ To maintain regulatory data base, submission, approval implementation of changes tracking 

▪ To compliance regulatory requirements and executes RA activities in line with defined procedures and processes. 

Aurobindo Pharmaceuticals Ltd, SEZ, Jadcherla, Hyderabad, Department: Quality Management System (QMS) Designation: Sr. Executive. Sept. 2020 to May 2021 

▪ GMP compliance, quality systems and shop‑floor oversight to ensure the manufacture and release of safe, effective, and compliant products. 

▪ To investigate and compile reports of batch failures, deviations, and market complaints. ▪ To review change controls, PNC, MNC, and investigation in the QMS system 

▪ To perform a risk assessment as per FMEA.

 ▪ To evaluate change control related to new product introduction and post approval changes as per SUPAC guidelines.

 ▪ To coordinate CAPA in the QMS system.

 ▪ To conduct Tier-I (Inter Dept. Audit), Tier-II (Self Inspection), and Tier-III (External Audit) audits at concern departments and ensure compliance in the Metric stream M7 module. 

▪ Audit response writing and submission. 

Zydus Cadila Healthcare Ltd. SEZ, Matoda, Ahmedabad Department: Quality Assurance (QA-RA) Designation: Executive. June 2016 to August 2020 

▪ Document management: GXP documents preparation, authorization, issuance and retrieval as per standard operating procedure.

 ▪ To prepare SOP and delivered training sessions to stakeholders to ensure compliance and efficiency. 

▪ To perform investigation of deviation, CAPA, market complaint, OOT, OOS, and batch failures.

 ▪ To perform risk assessment as per FMEA and evaluate change controls. ▪ To prepare and comply with an internal audit report. 

▪ Conduct the self-inspection audit of the department as per the schedule and to ensure and review the compliance of observation during self inspection. 

▪ Handling of market complaints and ADE. 

▪ Review of Executed BMR/BPR, QC Document Specifications, Stability Protocols, 

▪ Stability Data, Process Validation, and Qualification Documents. 

MBA in Pharmaceutical Management Sangai International University, Manipur, India – Post graduated with 61.46%. 

▪ Bachelor of Pharmacy Rajiv Gandhi University of Health and Sciences, Bangalore, Karnataka, Graduated with 72.28%.

 ▪ Higher Secondary School (HSC): Sarvajanik Vidhyalaya, Mehsana, India with secured 56.00%.

 ▪ Secondary School (S.S.C.): Sarvajanik Vidhyalaya, Mehsana, India with percentile 80.57%.