Regulatory Affairs CMC

Fifteen years of pharmaceutical industry experience achieving timely approval of several U.S. applications and dozens of supplements, accurately assessing the regulatory impact of hundreds of CMC changes and effectively supporting the global CMC regulatory effort

REGULATORY AFFAIRS - CMC SPECIALIST July 2016 – July 2017

ALKU Inc. on assignment at Takeda USA, Deerfield IL

Responsibilities

Provide post approval CMC regulatory support for assigned projects

Packaging site transfer for multiple products across multiple countries: authored CMC Module 1 Intro and updated applicable sections of Module 3

Contributed to compilation of a regulatory requirements matrix for global post approval filings

CONSULTANT March 2015 – March 2016

PAREXEL International Bethesda, MD

Parexel is a provider to the biopharmaceutical and medical device industries for the development and commercialization of new medical therapies worldwide.

Responsibilities

Support client’s regulatory activities via contribution to assigned project teams.

Contributions

Researched regulatory filing requirements for multiple proposed changes across numerous countries

Participated in an audit of analytical data generated by client’s contract testing laboratory

Prepared Module 1 documentation for client submissions

Participated in due diligence drug product file review to support client portfolio acquisition

Participated on the regulatory intelligence team

REGULATORY ASSOCIATE June 2013 – March 2015

Validant Consulting on Assignment at Alcon, Fort Worth Texas

Responsibilities

Marketed product liaison with CMC oversight for products manufactured at various Alcon manufacturing sites

Provided regulatory evaluation for change control

Authored post approval CMC supplements for assigned products: Module 1 Intro, applicable sections of Module 3 and Cover Letter

Supported the global regulatory affairs function, as assigned, including compilation of documentation in CTD format

Achievements

Authored several CMC supplements in CTD format

Evaluated about 70 product specific change controls

Provided CMC support to numerous country affiliates for dozens of global CTD submissions (original filings, variations and responses)

LECTURER, MARKETING August 2011– May 2013

Middle GA State College (formerly Macon State College) Macon, GA

MSC, within the state University System of Georgia, offers a variety of degree programs including associates degrees and four year degrees in select curriculum including business administration.

Responsibilities

Developed and delivered lectures and assessed student learning for several marketing courses:

Marketing Principles, Consumer Behavior, Services Marketing, Retailing, International Marketing

MANAGER, REGULATORY AFFAIRS May 2007 – April 2011

UCB, Inc. Smyrna, GA

UCB is a multinational pharmaceutical and biotech company focusing on the development of drug products to treat disorders of the central nervous system, respiratory system and digestive system.

Responsibilities

Marketed product liaison with CMC oversight for about twenty drug products

Authored CMC section of annual reports

Provided regulatory evaluation for change control

Authored post approval CMC supplements for assigned products: Module 1 Intro, applicable sections of Module 3 and Cover Letter

Addressed inquiries from drug safety and medical information

Supported business development activities

Supported the global regulatory affairs function - provided CMC assistance for filings to Health Canada

Achievements

Authored about forty annual reports

Authored more than a dozen CMC supplements – nearly all approved without Agency request for additional information

Evaluated about 200 product specific change controls

INSTRUCTOR, MARKETING August 2004 – May 2007

Dalton State College Dalton, GA

DSC, within the state university system of Georgia, offers a bachelor’s degree in select curriculum including business administration. Total college enrollment is about 4000 students.

Responsibilities

Developed and delivered lectures and assessed student learning for several marketing courses: Principles of Marketing, Advertising, Marketing Research & Analysis, Consumer Behavior, Sales & Sales Management, Services Marketing, Environment of Business and International Business.

MANAGER, REGULATORY AFFAIRS December 2001-November 2003

Mikart, Inc. Atlanta, GA

Mikart is a contract manufacturer of solid and liquid dosage form, generic pharmaceuticals.

Responsibilities

Directed the contribution of two regulatory associates

Authored, published and filed ANDAs

Reviewed CMC documents and facilitate revision as necessary including: batch records; raw material, finished product and stability specs and test methods; analytical data and method validation, stability protocols and data summaries

Prepared draft labeling, waiver requests and certification statements

Authored CMC for customer submission of INDs, NDAs, ANDAs and post approval supplements

Responded to Agency amendment notices or other related inquiries

Prepared petitions to the Agency and the USP

Interfaced with customers, consultants and the FDA, as appropriate, to facilitate petition or ANDA approval

Achievements

ANDAs Filed and Approved: eight original Mikart sponsored and at least ten original customer sponsored

Amendments filed more than a dozen

Petitions filed more than a dozen

QUALITY COMPLIANCE ANALYST March 2000 – May 2001

Quintiles Laboratories Smyrna, GA

Quintiles is a global, full service clinical research organization supporting the pharmaceutical and biotechnology industries. The laboratory in metro-Atlanta is one of several worldwide that provides analytical testing in support of clinical trials.

Achievements

Conducted internal and sub-contractor audits in accordance with GLP, GMP, CLIA and NCCLS guidelines

Prepared customer audit responses

Directed investigation of field and internal incident reports; assessed and approved proposed CAPA

Performed facility, process, project and data audits

Reviewed analytical method and equipment validations

REGULATORY COMPLIANCE ADMINISTRATOR / CHEMIST June 1992 - December 1997

Napp Technologies, Inc. Saddle Brook, NJ

Napp Technologies manufactured specialty chemicals and bulk pharmaceuticals.

Achievements: Regulatory Affairs and Process Development

Authored documents for regulatory submission: DMFs & updates, audit responses, general communication

Interfaced with FDA agents regarding data audits, international supplier audits and miscellaneous communication

Performed process and cleaning validations: developed protocols, monitored procedures & sampling, compiled data and prepared validation reports for FDA submission. Reviewed and edited validation reports for analytical instruments and API manufacturing equipment.

Composed and revised SOPs for QC, QA, R&D, & Mfg to improve GMP compliance

Coordinated the drug substance stability program

Performed multi-step pharmaceutical synthesis, from patent and literature review to manufacturing evaluation

EDUCATION Fairleigh Dickinson University Madison, NJ

Bachelor of Science, Chemistry

Master of Business Administration

Contact this candidate