| | | 20,000+ Fresh Resumes Monthly | |
|
|
| |
Click here or scroll down to respond to this candidate Candidate's Name
EMAIL AVAILABLEPHONE NUMBER AVAILABLE
PROFESSIONAL SUMMARY: A seasoned Regulatory Professional experienced in Regulatory CMC submissions, IND, ANDA, BLA and Labeling. Developed high-quality QOS (Module 2) and CMC (Module 3) documents. Liaison with different cross-functional teams like Regulatory medical writing and Quality Assurance to ensure timely regulatory submissions. Assisted in collecting and coordinating information for regulatory documentation packages for CTD submission. Complied with the company s SOPs and regulatory requirements and adherence to company standards, templates, and style guides. Assisted in reviewing and submitting change control requests. Liaison with different departments like QA, Drug Safety, Clinical, and Manufacturing. Involved in the preparation of CTD non-clinical and clinical documents. Literature search and metadata analysis from PubMed, Ovid, Embase, and TOXNET. Basic understanding of regulatory guidance documents of ICH, FDA, and EMEA
PROFESSIONAL WORK EXPERIENCE:
JANSSEN BIOTECH (JOHNSON & JOHNSON PHARMACEUTICAL)- MALVERN- PA- USAJan 2024- Present, Operation Co-Op. Handling All the Documentation Related to CMC and Gene Therapy. Monitoring and Proving Documentation Support Related to Manufacturing Plant as per SOP and USFDA. Managing Downstream Support for DPC, Supply Chain, Storage Facilities, CMC Regulation, and MSME. Handling All the Documentation Related to CMC Regulation. Managing Downstream Support for DPC, Supply Chain, and Storage Facilities. Develop/modify protocol and report templates. Resolve protocol deviations as they arise. Review of design documentation, specifications, and related documents as they relate to validation like change control, FMEA and Obsoletion.
LONG ISLAND UNIVERSITY- BROOKLYN- NYC- USASept 2023- Dec 2023, Graduate Assistant. Handling All the Educational Material and thesis and updating new changes of FDA s rules, guidelines, and Regulations for the Pharmaceutical, Medical Device, and BioPharma Industry to the University for better Current ongoing Trades. Teaching Assistantship for the Subject Pharmacy Profession and Health, Pharmacy and Society of Pharm D department.TRANSLUMINA Therapeutics Private Limited, Medical Device Group.June 2020 Aug 2022, Clinical Regulatory Affairs Specialist Develop Regulatory strategies for new and modified medical devices, provide guidance, and feedback to regulatory affairs management, and prepare, analyze, and submit internal regulatory file applications and supporting documentation like 510k submission, IND, and NDA. review medical device labeling and advertising materials for accuracy and completeness and create and submit state and federal licensing applications. Design Clinical Trials and focus on inclusion-exclusion criteria including data collection and analysis as well as finding out outcomes based on biostats calculation for preparation of FDA meetings. Organize Training for Cath lab technicians and Doctors for different Procedures and device preparation for different procedures.Abbott Healthcare Private Limited.April 2019 May 2020, Senior Key Account Manager I used to get approval from government agencies regarding my drug formulation based on safety reports as per FDA regulation guidelines and do the regulatory works regarding Anti-diabetic drugs. Promoted Enoxaparin, Streptokinase, Tenecteplase, ACITROM, and Dabigatran injectable portfolio to the cardiologist doctors. Organized patient education programs for awareness of Blood clots, DVT, MI, and Heart Failure.
INTAS Pharmaceutical Private Limited.July 2014 March 2019, Are Business Manager. Manage 4 teams of members. Support product clinical trials and Product Queries in front of diabetologists, nephrologists, and cardiologist doctors along with subordinators based on the regulatory guidelines and collect all required documentation for real-world clinical trial publication even for drug development. Organized patient education programs, blood sugar camps, and demonstrated Injectable high-risk medicine to the patients, and gave diet and nutrition tips to the diabetes patients.
CLINICAL INDICATIONS:
Cardiology: Coronary Artery Disease, Coronary Valve Disease, Stroke, Heart Failure, Hypertension, Hyperlipidemia,Neurology: Stroke, Coiling, ICAD.Peripheral: Varicose Vein, Peripheral Artery Disease. Nephrology: End Stage Renal Disease, Chronic Kidney Disease, Anemia,Diabetology: Type 1 and Type 2 DiabetesLICENSES, CERTIFICATIONS & TRAINING: GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus) SIX SIGMA: BLACK BELT by International Institute of Business Analysis (IIBA) LEAN SIX SIGMA FOUNDATION Good Clinical Practice (U.S. FDA Focus) IMPELLA - Left Ventricular Assisting Device Training by ABIOMED Shockwave Console and Procedure Training by SHOCKWAVE
EDUCATION:Master s Degree of Regulatory Affairs (DRA), Long Island University, Brooklyn- NY(Sept 2022- May 2024, Current GPA- 3.86)Bachelor s Degree of Pharmacy (B. PHARM), - NIRMA University
(June-2010 - May 2014, GPA- 3.65)
COMPUTER SYSTEMS: Microsoft Office Suite, Clinical Conductor Enterprise (CCE, & CCS), eCube, Epic Clinical Research IO (CRIO) TruVault, Minitab |
