Aakash Panchal

ad37wt@r.postjobfree.com

315-***-****

PROFESSIONAL SUMMARY:

A seasoned Regulatory Professional experienced in Regulatory IND, NDA, ANDA and 510(k) Submission.

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.

Liaison with different departments like QA, Drug Safety, Clinical and Manufacturing.

Involved in preparation of CTD non-clinical and clinical documents.

Literature search and metadata analysis from PubMed, Ovidsp, Embase and TOXNET.

Basic understanding of regulatory guidance documents of ICH, FDA and EMEA

PROFESSIONAL WORK EXPERIENCE:

JANSEEN BIOTECH (JOHNSON & JOHNSON PHARMACEUTICAL)- MALVERN- PA- USA

Jan 2024- Present, Operation Co-Op, Full-Time.

Contribute to the overall development, implementation, and execution of activities for the Janssen Malvern site as per GMP Requirements. Work closely with assigned personnel on new and existing projects, process improvements, and cost reduction efforts like SOPs, Downstream Processes, MSME, Support new product technology transfer to the Malvern site.

Handling All the Documentation Related to CMC Regulation. Managing Downstream Supporting for DPC, Supply Chain, Storage Facilities.

Review of design documentation, specifications, and related documents as they relate to validation.

Resolve protocol deviations as they arise.

LONG ISLAND UNIVERSITY, BROOKLYN- NYC- USA

Sept 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, Gujarat State, India

April 2019 – 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 outcome based on biostats calculation for preparation of FDA meetings.

Abbott Healthcare Private Limited, Gujarat State, India

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.

exceeded the yearly sales targets by 15% and earned certificates and incentives for brand achievement.

Organized patient education programs for awareness of Blood clots, DVT, MI, and Heart Failure as per Regulation Guidelines.

INTAS Pharmaceutical Private Limited, Gujarat State, India

Sept 2014 – March 2019, Business Manager.

Manage 4 teams of members.

Support product clinical trials and Product Queries in front of diabetologists, nephrologists, and cardiologist doctors along with sub Ordinator’s 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 Diabetes

LICENSES, CERTIFICATIONS & TRAINING:

LEAN SIX SIGMA FOUNDATION

SIX SIGMA: GREEN BELT by International Institute of Business Analysis (IIBA)

GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus)

Good Clinical Practice (U.S. FDA Focus)

Working with the IACUC (Curriculum Group) Research Administrators - Working with the IACUC (Course Learner Group) 1 - Lab Animal Research (Stage)

IMPELLA - Left Ventricular Assisting Device Training by ABIOMED

Shockwave Console and Procedure Training by SHOCKWAVE

EDUCATION:

Long Island University, Brooklyn- NYC- USA. Master’s Degree of Regulatory Affairs (DRA),

(Sept 2022- May 2024, Current GPA- 3.86)

NIRMA University, Gujarat- India. Bachelor’s Degree of Pharmacy (B. PHARM),

(June 2010 - May 2014, GPA- 3.6)

COMPUTER SYSTEMS:

Microsoft Office Suite, Clinical Conductor Enterprise (CCE, & CCS), eCube, Epic

Clinical Research IO (CRIO)

TruVault

MINITAB

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