| | | 20,000+ Fresh Resumes Monthly | |
|
|
| | Related Resumes Project Manager Scrum Master Old Bridge, NJ Business Analyst Project Manager Jersey City, NJ Project Manager Equipment Operator Doylestown, PA Carpenter, Lead Carpenter, Shop Foreman, Project Manager Jersey City, NJ Senior Project Manager Philadelphia, PA Risk Management Project Plainsboro, NJ Project Management Senior Jersey City, NJ |
|
Click here or scroll down to respond to this candidateCandidate's Name
Regulatory Affairs ConsultantFormer FDA Reviewer and Policy AnalystReviewed 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 centersSummary of Qualifications35 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, BLAs, ANDA's and DMF'sPromptness in preparing Amendments and SupplementsAccurate and detailed assembly of all data tables for annual report submission.Comprehensive knowledge of government requirements for pharmaceutical product development in the US and abroadSuccessfully 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 agenciesNumerous discussions with FDA and other regulatory bodies about pending NDA's, IND's, CTA's etcPreparation 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 membersFrequent communications with all section heads includes all team members in decision process.Coordinates with project manager on product life cycleProvides sound regulatory strategies for achieving deliverableObtained market approvals of U.S. products in Great Britain, Ireland and JapanExperience:Job TitleRegulatory affairs CMCManager CMC / Regulatory Strategist at Sanofi-AventisDates Position HeldDecember 2015December 2016Job Overview/Job ResponsibilitiesManaging 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 interpretation of 21 CFR 210, 211, 312, 314 for R.A department and customers.Job TitleRegulatory affairs CMCContractor / Consultant in Regulatory CMCCompliance insight and Beaufort, LLCDates Position HeldSeptember 2013December 2015Job Overview/Job ResponsibilitiesProvide regulatory advice and solutions for a variety situation that clients encounter during the submission process. Also provide Interpretation of regulations and guidance s as they pertain to specified problems.Job TitleManagerRegulatory affairs CMCContractor / Consultant in Regulatory CMCSPI PharmaDates Position HeldMay 2013July 2013Job Overview/Job ResponsibilitiesProvide regulatory support for a variety of projects, from assembly of DMF/ CTD formatted documentation to writing sections of import export policy.Job TitleRegulatory affairsManagerContractor / Consultant in Regulatory CMCMillenniumDates Position HeldFebruary, 2012September 2012Job Overview/Job ResponsibilitiesProvide 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/Company NameContractor / ConsultantRegulatory CMCNovartisDates Position HeldOctober, 2011 January, 2012Job Overview/Job ResponsibilitiesPerformed regulatory compliance review for both OTC and prescription medications. Prepared template used by entire organization to record and track current and past CMC practicesRegulatory Direction2003 - PresentPrincipal ConsultantProvided regulatory consult to the advertisement and promotion team. The Team met regularly to deal with all promotional and advertising for both newly approved product as well as currently marketed products. The team would also address concerns expressed by the FDA and the FTC a about OTC and Nutracuetical products.Provided regulatory advisories and contracted project management services to pharmaceutical and chemical companies to facilitate timely and complete NDA, IND, ANDA and DMF submissions.Performed quality systems audits and gap analysis and prepare necessary SOPs to conform to government filing.Gave expert strategic regulatory filing guidance, including devising CAPA and change control systems.Crafted language to address deficiency responses and FDA form 483 observations.Directed negotiations with FDA on behalf of clients to resolve outstanding application deficiency issues.Provided evaluation of the technical and manufacturing capabilities of potential outsource partners in Puerto Rico and Canada, including: site regulatory and cGMP compliance.Evaluation of integrity of product stability and packaging records, and validation of analytical methods; pilot plant-to-scale-up equipment validation evaluation.Wyeth1999 to 2003Associate Director of Regulatory AffairsReviewed 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 teamsInfluenced all levels of staff, executive management, government agencies and external contractors and service providers to support efficient drug product development and achieve corporate goalsWorked 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 budgetPlanned and prioritized projects for RA department.Coordinated flow of information required for FDA submissions.Facilitated generic drug workshop sponsored by the International Research, Pharmaceutical DivisionMylan Technologies (formerly Bertek, Inc)1996 - 1999Manager, CMC, Regulatory AffairsFiled 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, MD1991 - 1995Review ChemistReviewed 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 - 1991Supervisory ChemistAssured 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, Pfizer, McNeil Pharmaceuticals, Quintiles, Alpharma, Lantheus Medical Imaging, and Mayne Pharmaceuticals, Biogen idecEducationCheyney University, Cheyney, PABA, ChemistryChemistry Club, ACSUndergraduate research on Terpenes and NitrosamineContinuing EducationUniversity of Maryland, School of Pharmacy / FDACertificate of Pharmaceutical TrainingEducational Lecture Series in Pharmacy and Pharmaceutics - Team building, NegotiatingSkillsExcellent 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 AffiliationsAmerican Chemical SocietyRegulatory Affairs Professional SocietyParenteral Drug Association |
