KRUNAL PATEL

acwl5l@r.postjobfree.com

Mobile: 201-***-****

Jersey City, NJ

Job Objective: To obtain a Regulatory position that will promote growth, stability and opportunity for advancement.

CORE COMPETENCIES:

Extensive understanding of submission types, requirements and options for US, Canada and Australian agencies. Extensive Knowledge of International drug regulatory process

Familiarity with latest FDA guidance’s, Medical terminologies, Biologics, Medical Devices, Regulatory terminologies and processes.

Comprehensive knowledge about general mechanics of clinical trial, insights on content of clinical trial application, marketing authorizations, role of human subject in research, considerations for international clinical trials and ethical issues to be considered during a trial. Awareness of legal liabilities of sponsor during clinical trials.

Complete knowledge of Drug Development Process

Thorough Knowledge about Medical Devices, 510k Submission, Class II, Class III Medical Devices.

Thorough knowledge of new drug development processes such as Pre-IND interactions, IND, NDA, MAA, SPA filings with the FDA to obtain marketing approval. Complete knowledge of the eCTD sections and format.

Proficient with Biologic IND and BLA process.

Capability to support crosses functional activities and conduct regulatory intelligence required to support development and implementation of short and long term strategies.

Basic understanding of Canadian and Australian device approval/ regulatory pathways/requirements, GHTF/IMDRF objectives and post marketing requirements.

Profound Knowledge in FDA regulated Quality Systems; including document control, auditing, investigations/CAPA, 21 CFR Part 11

Aptitude to understand project needs and provide analysis of the newly issued regulatory guidance.

Keen interest of the evolving regulatory landscape of the emerging markets (Example- Latin America, Europe, Japan and Australia).

Knowledge and proficiency of “eCTD express”

eCTD submission

PROFESSIONAL EXPERIENCE:

SIEMENS HEALTHCARE, MALVERN, PA (Nov 2015- May 2016)

Regulatory Affairs Intern

Assisted in the identification of and internal distribution of Regulatory and Standards topics

Supported and collaborated with internal Regulatory and Standards subject matter experts to examine emerging key Regulatory policy issues under the direction of Coordinator, International and Domestic TRS.

Attended as needed the internal and external Regulatory and Standards meetings (e.g. MITA, AdvaMed working group teleconferences) and provide reports from those meetings to Coordinator, International and Domestic TRS.

Provided reports as needed on Regulatory and Standards activities. This includes assistance in generating routine internal reports as well as providing reports (synopsis, outcomes, action items) from meetings, FDA related events, and all affiliated trade organization teleconferences, meetings and events

Facilitate the exchange of information with external industry trade organizations under the direction of Coordinator, International and Domestic TRS.

GUJARAT PHARMACEUTICALS, INDIA (2012-2014)

Regulatory Affairs Associate

Responsible for authoring or drafting cover letters and FDA forms and planning, publishing, reviewing, and/or archiving IND and NDA electronic Common Technical Document submissions, including protocol amendments, information amendments, general correspondence, safety reports, annual reports, CMC post approval change supplements, Structured Product Labeling (SPL), and other submissions.

Collaborate with the Head Office's Regulatory Department regarding national

product submissions and regulatory topics (510(k)s, labeling and promotional

materials, complaints handling, FDA Medical Device Reporting (MDR), OSHA,

etc.).

Preparation and provision of supporting documentation to Corporate Regulatory Affairs to afford submission of new drug applications (i.e. ANDA per 505(j), NDA per 505(b)(2), and NDA per 505(b)(1).

Preparation of major CMC portions of the Common Technical Document (CTD) for electronic paper applications in support of new drug applications.

Under oversight of a US and Canada Area regulatory strategist, supported in development and marketed submissions on behalf of pharmaceuticals, biologics, and combination products, such as Advicor, AndroGel, Biaxin, CREON, Depakote, DepakoteER, Depakote Sprinkles, Duopa, Gengraf, Kaletra, K-Tab

Knowledge of eCTD Submission and have submitted Modules 3 “quality Data” through “eCTD express”

Knowledge working experience of both Electronic and Paper Documentation of data

Prepared clinical narrative summaries for ‘Adverse Event’.

Ensured timely coverage to Regulatory Authorities and pharmacist.

Participated in preparing safety reports and maintained clinical databases.

Ensure compliance by partnering with management to update templates, Standard Operating Procedures (SOPs), and job aid documents. Present to all Submission Operations staff and train publishers to draft FDA cover letters, Form FDA 1571s, Form FDA 3674s

Preparation of Letters of Intent to afford the import of any FDA-retained drug products or components into the U.S.

Preparation of Annual updates Drug Master Files (DMFs).

Responsible for other supporting RA activities (i.e. maintenance of regulatory filing system, etc.)

Handled Module 3 “QUALITY DATA “of ANDA for Arthritis Drug

EDUCATION

Masters of Science in Drug Regulatory Affairs

Long Island University, Brooklyn, New York City

May 2016

Bachelors of Pharmacy (B.Pharm) from Rajiv Gandhi University of Health Sciences, Bangalore, India.

Sept 2012

CERTIFICATION:

Registered Pharmacist

Pharmacy council of India 2012

ORGANIZATION:

Regulatory Affairs Professional Society (RAPS), Member

Starting February 2015

San Diego Regulatory Affairs Network

Member

Starting June 2016

Skills:

Complete Proficient with Microsoft Office MS Word, Excel, PowerPoint MS-Project, MS SharePoint

Exceptional facilitator and communicator with great inter personal skills.

Excellent verbal and written communication skills

Strong organizational skills

Outstanding analytical and problem-solving abilities

Excellent profiency with software tools and metrics and good Multi-tasker

SEMINARS AND PROJECTS:

Submitted project on the subject Bio pharmaceutics that includes topics like Blood level curves for I.V, oral I.M.

Completed project on FDA regulatory approval for LIPITOR (atorvastatin calcium). Described FDA guidance documents, Pre-clinical & clinical safety data, financial statistics of Pfizer, Post marketing surveillance and regulatory history of Lipitor

eCTD publishing and have worked on MODULE S IND, NDA submission

Contact this candidate