Manager Data

Nilam Patel, R&D RA scientist/Analytical Chemist-III

B.A. in Biology, MS in Regulatory Affairs

Email: **********@*****.***

Cell- 201-***-****

OBJECTIVE:

Seeking Regulatory Affairs associate job in a growth oriented progressive environment that offers learning opportunities and contribute from my skills and experience.

PROFESSIONAL EXPERIENCE:

R&D – RA Scientist (Contractor) at Johnson & Johnson Consumer Companies, Inc., Skillman and Titusville New Jersey, September 2015 to present

Responsibilities include:

Performing method validations and required testing for new HPLC, UHPLC and UV Spectrophotometer methods for consumer, OTC and health care products.

Developed preservative and antibiotic methods for better chromatography conditions.

Performing Viscosity testing for establishing parameters for product specifications and in support of investigations.

Conducts Investigations for any OOS or OOT and implement CAPAs as needed

Initiating and routing Global Change Controls (GCCs) for updating multiple Product Specifications or Test Methods (Trackwise).

Assisting in drafting method validation reports, transfer reports and stability reports for the team as needed.

Perform technical transfer activities and compile and provide supportive module 3 document for RA submissions (US and Canada).

Collaborate with different groups and CMO to prepare the CMC section of INDs, NDAs, amendments, supplements and annual reports, including the compilation and review of the required data (validation report, stability data, tech transfer report; etc.).

Identify and communicate routine CMC issues, development or revision Of SOP under supervision and proof reading of lab generated documents.

Review and approve CMC change controls for US application (Specific to 32p5).

Assist in preparation of risk assessment and contingency plans for CMC regulatory strategies and dossiers.

Experience is submitting New investigator submissions and maintaining current 1571 form.

Uploading and circulating all submission ready document in to NextDoc and Veeva system for final publishing after performing internal bookmarking and hyperlinking. Archive all submission, FDA correspondence, FDA email communication in to Regulatory drive.

Keep track of commitment log timeline/tracker, project tracker.

Liaise with CMC operation team to make sure documents are in compliance with Starting point templet requirements also assist in identifying submission ready document templets.

Train new hirers as and when needed

R&D scientist:

Sannova Analytical Inc., Somerset, New Jersey, April 2014 to August 2015

Chemist, Quality Control

Responsibilities:

Analyzed biological samples using HPLC for bioequivalence and bioavailability studies.

Performed Wet Chemistry testing.

Performed assay studies of active drug ingredients and metabolites.

Reviewed method validation reports and OOS investigation reports for adherence to Methods, Protocols and SOPs.

Assisted in the management of stability samples for Controlled Room Temperature studies and provide it to regulatory affairs for annual report submission.

Experience in representation R&D and Interact with Research & Development, Quality Assurance/Quality Control (QA/QC), Production for gathering data and documentation for Regulatory submissions.

Performed physical tests using pH meter and Viscometer.

Supported the Laboratory Manager updating SOPs and reviewing Technical Operators training documents.

Skills:

Knowledge of the US and Global regulatory environments, Post approval CMC changes guidance and review of Stability data (IND, NDA, MAA, CTA).

Knowledge of FDA, ICH, USP guideline, 21 CFR Part 7.

Excellent experience in GxP environment

Proficient in Connect, NextDoc, PRISM, eCTD viewer, Microsoft Excel, Microsoft Power Point, Microsoft word, Microsoft Access, Microsoft Outlook, SharePoint, Trackwise change control system

Knowledge of eCTD documentation standards and publishing workflows.

In-depth knowledge in desktop applications, (Microsoft Office, Adobe), core template and model document usage.

Knowledge of IRB and clinical study Protocol review monitoring committee

Had 6month data management project during master degree where responsible drafting clinical study data and presenting clinical study process

Education:

MS in Regulatory Affairs (Northeastern University) Jan 2016- Sep 2017

BS in Biology (New Jersey City University) Jan 2009-Dec 2013

References: Available upon request

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