Lamont Michael Fulton

Regulatory Affairs Consultant

Former FDA Reviewer and Policy Analyst

Reviewed hundreds of Drug Applications submitted to the FDA for market approval in the United States. Served as adviser to the Office of Regulatory Affairs to resolve citizen petition issues, worked as Policy analyst in the Office of International Policy on Harmonization issues for all centers

Summary of Qualifications

●35 years of industry experience with over 20 years in Regulatory Affairs and Compliance (including 5 years at FDA as a CMC reviewer, and analyst)

●Expert reviewer of CMC sections for IND's, NDA's, BLA’s, ANDA's and DMF's

●Promptness in preparing Amendments and Supplements

●Accurate and detailed assembly of all data tables for annual report submission.

●Comprehensive knowledge of government requirements for pharmaceutical product development in the US and abroad

●Successfully communicated with CMC reviewers from both domestic (FDA) and international (MCA, MHW, EU) regulatory agencies.

●Periodically updates are made to global databases (ICH guidelines, and CTD format issues)

●Ability to communicate and negotiate successfully with foreign and domestic regulatory agencies

●Numerous discussions with FDA and other regulatory bodies about pending NDA's, IND's, CTA's.

●Preparation of a pre-IND packages for both small and large molecule submissions.

●Worked with various international (Germany, Italy, India) suppliers and other external resources of type II III and IV materials used in the production of product.

●Team oriented professional with extensive experience in reviewing documentation and detecting and correcting deficiencies.

●Practices positive reinforcement with staff members

●Frequent communications with all section heads includes all team members in decision process.

●Coordinates with project manager on product life cycle

●Provides sound regulatory strategies for achieving deliverable

●Obtained market approvals of U.S. products in Great Britain, Ireland and Japan

EXPERIENCE CONTRACT

LAST ASSIGNMENT

DATES HELD

MAY 2021 THRU November 2022

Job Title

Lead Regulatory CMC Consultant for (MTDA) Mitsubish Tanabe Pharma America

Assisted clinical team member with the development and preparation of IND’s and IMPD’s

Worked on briefing books and SA communications for USA and EU regulatory submission.

Reviewed and assembled Modules 1, 2 (QOS) and 3 for global submission (NDA, MAA, CTA).

Provided support to third party contractors (Change controls, annual reports, supplements)

Responsibilities

Job Title

CONSULTANT

DATES HELD

OCTOBER 2020

November 2020

Responsibilities

Pre IND-Consultation for a research IND submission to FDA

Sub contract to (1099) Compliance Insight (work from home)

5850 Boymel Drive suite 1, Fairfield, OH 45014

Job Title

Consultant

Dates Held

September 2020

November 2020

Responsibilities

Consultation (1099) provided via Epsilon TEK Inc. consultation services and information technology to Merck for CMC projects

Job Title

SENIOR DIRECTOR of Regulatory CMC- GLENMARK Pharmaceutical

Dates Position

Held

January 2019

April 2019

Responsibilities

Prepare, coordinate, and assemble various submissions to the FDA, such as original new ANDAs, DMFs, and related application correspondences such as annual reports, amendments, and supplements.

Coordinate, assemble and/or prepare for submission various materials to the Canadian Therapeutic products Directorate, such as ANDS/DMFs/ARs and amendments/supplements.

Represent our client and establish productive relationships with appropriate FDA personnel / TPD personnel and to assure that the Company has an understanding of all applicable laws, regulations, guidance.

Support Marketing, Distribution, Global Regulatory Affairs functions as and when required.

EXPERIENCE CONTRACT

Job Title

Manager CMC Regulatory

CATALENT

Dates Position

Held

March 2018

June 2018

Responsibilities

As Regulatory Affairs Manager it was my primary duty to support:

●Product development

●Manufacturing activities

●Compliance with GMP regulations.

●Prepare and file regulatory submissions for various clients.

Job Title

Manager CMC / Regulatory Strategist at Sanofi-Aventis

Dates Position Held

December 2015

December 2016

Responsibilities

Managing regulatory affairs CMC teams and preparing control documentation for the submission of drug applications to the FDA. Provided regulatory strategies and advice, as well as writing position papers for the possibility implementation of policy. Worked on controlled correspondence to the FDA and assisted management in response to FDA queries. Provided written inter

Job Title

Contractor / Consultant in Regulatory CMC

Compliance insight and Beaufort, LLC

Dates Position Held

September 2013

December 2015

Responsibilities

Provide regulatory advice and solutions for a variety situation that clients encounter during the submission process. Also provide Interpretation of regulations and guidances as they pertain to specific problems.

Job Title

Contractor / Consultant in Regulatory CMC

SPI Pharma

Dates Position Held

May 2013

July 2013

Responsibilities

Provide regulatory support for a variety of projects, from assembly of DMF/ CTD formatted documentation to writing sections of import export policy.

Job Title

Contractor / Consultant in Regulatory CMC

Millennium

Dates Position Held

February, 2012

September 2012

Responsibilities

Provide regulatory consult as needed and prepare documentation for filing and archiving as requested. Also, reviews CMC portions of IMPD, NDA, CTX and global applications for later submissions to pertinent regulatory authorities.

Job Title

Contractor / Consultant

Regulatory CMC

Novartis

Dates Position Held

October, 2011 January, 2012

Responsibilities

Performed regulatory compliance review for both OTC and prescription medications. Prepared template used by entire organization to record and track current and past CMC practices

EXPERIENCE PERMANENT

Wyeth 1999 to 2003

Associate Director of Regulatory Affairs

●Reviewed and approved promotional material before submitting to DDMAC. I provided regulatory guidance and counsel to the copy clearance committee at Wyeth.

●It was my charge to make sure that all items produced for the sale of product followed the regulation per Division of Drug Marketing, Advertising, and Communications (DDMAC). It also was my charge to make sure that all advertisements and promotional labeling were properly prepared for submission (FDA form 2253) to DDMAC as per21 CFR 314.81(b) (3) (i).

●Directed regulatory functional groups for cGMP and pre-approval inspections.

●Recruited, hired, trained and mentored regulatory staff.

●Established and led results-oriented, high performance regulatory project teams

●Influenced all levels of staff, executive management, government agencies and external contractors and service providers to support efficient drug product development and achieve corporate goals

●Worked with project managers to facilitate successful product launches, as well as product performance investigations.

●Spearheaded transition of products to other pharmaceutical firms.

●Developed and managed multimillion dollar departmental budget

●Planned and prioritized projects for RA department. Coordinated flow of information required for FDA submissions.

●Facilitated generic drug workshop sponsored by the International Research, Pharmaceutical Division

Mylan Technologies 1996 - 1999

Manager, CMC, Regulatory Affairs

●Filed Market applications to various International regulatory bodies (the MCA in the United Kingdom, the MHW in Japan, and the IMB in Ireland etc.).

●Obtained first generic approval of transdermal patch for nitroglycerin and set stage for the first transdermal approval of Fentanyl.

●Coordinated strategic regulatory planning for the preparation of IND/NDA/ANDA filings to the FDA.

●Organized and supported Chemistry, Manufacturing & Control tasks in the area of, annual updates, supplements and amendments. Prepared Drug Master Files (Type III and IV) for Medical products division.

●Provided training as needed to non-regulatory personnel.

US Food and Drug Administration, Rockville, MD 1991 - 1995

Review Chemist

●Reviewed hundreds of Abbreviated New Drug Applications, and New Drug Applications submitted to OGD for market approval in the United States.

●Assisted the International Office of Policy as a Policy Analyst in their endeavor to facilitate Global Regulatory issues dealing with EU, ISO and ICH.

●Worked on Regulatory affairs dealing with Citizen Petitions and public inquires (e.g. unspecified protein characterization of biological products)

Glaxo-Smithkline (formerly SmithKline Beecham)1984 - 1991

Supervisory Chemist

●Assured quality and purity of incoming raw material and finished product by scheduling analytical tests and supervising and reviewing manufacturing records and laboratory test results.

●Organized and oversaw all quality control functions inside the QC laboratory.

●Developed detailed instructions for operators to facilitate batch testing during manufacturing process.

Client List: Elite Laboratories, Steifel labs, Pfizer, McNeil Pharmaceuticals, Quintiles, Alpharma, Lantheus Medical Imaging, and Mayne Pharmaceuticals, Biogen idec, Millenium, Novartis, Compliance insight, Beaufort Inc, SANOFI AVENTIS, FDARQA

Education

Cheyney University, Cheyney, PA

BA, Chemistry

●Chemistry Club, ACS

●Undergraduate research on Terpenes and Nitrosamine

Continuing Education

University of Maryland, School of Pharmacy / FDA

●Certificate of Pharmaceutical Training

●Educational Lecture Series in Pharmacy and Pharmaceutics - Team building, Negotiating

Skills

●Excellent analytical abilities.

●Ability to research and resolve problems.

●Strong negotiating skills.

●Team builder with ability to train and develop others.

●Performance driven with well-developed organizational skills.

●Computer literate - Word, Word Perfect, Excel.

●Working knowledge of Russian and Swahili.

Professional Affiliations

●American Chemical Society

●Regulatory Affairs Professional Society

●Parenteral Drug Association

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