Regulatory Affairs professional currently working within the pre- and post-approval spaces, providing registration and lifecycle support for Lannett products. Experience includes preparation of Abbreviated New Drug Applications (ANDA), post-approval supplements/variations, annual reports, and responses to FDA requests. Also conduct critical review of key technical documents to ensure scientific accuracy, completeness, regulatory compliance, and consistency with other key documents. Additional professional experience includes two years Global Pharmaceutical Regulatory Affairs (CMC) and nine years as an analytical chemist at Merck Sharp and Dohme. Expertise in areas of analytical methods development, clinical release and stability analysis of multiple dosage forms under GMP/GLP environment, data interpretation and reporting, and authoring of scientific documentation.
MS Office Applications, Documentum (Regulatory authoring tool), ORION, Global Change Management (Change control system)
August 2002Bachelor of Science:Temple University - ChemistryPhiladelphia, PAChemistry 3.50
May 1998Associate:Community College of Philadelphia - Applied Science Chemical TechnologyApplied Science Chemical Technology 4.0 Highest Honors
Senior Regulatory Affairs Associate11/2013 － CurrentLannett Company, IncPhiladelphia, PA
Successfully authored and submitted full aNDAs for two combination solid oral dosage form products and one oral solution drug product.
The applications consisted of Modules 1, 2, 3, 5 and labeling in eCTD format.
Responsibilities include review of change controls, batch records, product development reports, and packaging records.
Additional activities include performing regulatory assessments of post-approval changes, filing multiple Changes Being Effected (CBE) and annual reports for several products.
Regulatory Affairs Specialist11/2011 － 11/2013Merck Sharp and Dohme CorpWest Point, PA
Developed regulatory strategy, prepared CMC sections and responded to Agency questions in support of a confidential network source of supply change.
This change was filed in over fifty markets and consisted of a technology transfer to an external manufacturing site, an associated batch size increase, and specification widening.
Participated in development of a structure within regulatory authoring tool to populate with documents and quality sections common to aforementioned submissions to Most of World markets. Once fully populated, this strategy reduced the managerial review time of each submission by an estimated fifty percent.
Experienced in preparation of market-specific declarations and templates.
Authored 2012 and 2013 US annual reports for three mature products and submitted each prior to FDA committal dates.
Authored an emergency Type IA UK submission for a process change previously submitted in 2010. This was completed and released within the required fourteen days of notification, ensuring no interruption to product supply.
Prepared product registration renewal submissions for markets in the European Union, Asia-Pacific, Latin America, and the Middle East.
Provided responses to multiple health authority requests across three in-line product franchises.
All responses were provided within established timeframes, ensuring product license maintenance.
Provided day-to-day regulatory support for two marketed products.
This included site support, health authority responses, tender bids, and general inquiries.
Also provided regulatory assessments for proposed process changes using internal client CMC systems for change control and tracking.
Research Chemist08/2007 － 12/2011
Merck Research Labs Lead GMP analytical project chemist for several early phase programs supporting both target to Phase IIb compounds and Experimental Medicine (EM) formulations.
Laboratory responsibilities included developing/validating chemical and physical characterization methods for complex topical and intravenous (IV) dosage forms, release and stability testing for clinical materials.
Additional responsibilities included critical data review, preparation of regulatory documentation, authoring of CMC stability sections to support IND filings, and presentation of data to product teams.
Developed a stability-indicating method to simultaneously analyze several topical formulations (solutions, petrolatum-based, creams).
Each formulation required successful development of sample extraction procedure.
Provided all GLP and GMP analytical support (stability, release) for potency selection of chosen topical cream formulation.
Developed novel methods to measure physical properties of the cream such as moisture and pH determination.
Successfully generated results and authored relevant CMC sections within accelerated timelines.
Efforts contributed to achieving First in Human milestone within nine months of first GLP mini-pig study.
Managed GMP analytical project work for eight Experimental Medicine sterile parenteral formulations.
Support included all method development and validation as well as setting up probe and IND stability studies.
Results generated supported technical justification for reevaluation date extension of clinical supplies.
Designed and executed dosing device compatibility studies (extractable/leachable) for parenteral formulations.
Results of each study contributed to dosing and material handling instructions for clinical sites.
Staff Chemist, Merck Research Labs02/2017 － 08/2007
Lead GMP chemist for multiple early phase formulations, providing analytical methods development and validation support.
Trained to become proficient in GLP requirements to provide analytical support for Safety Assessment studies.
Developed and validated GLP analytical methods and provided required documentation to enable Safety Assessment study starts within established timeframes.
Performed testing of probe stability/IND supplies and clinical release supplies.
Also provided analytical support for formulation characterization as well as peer review of scientific data.
Departmental representative on the Controlled Release Technology Development Team.
Conducted and applied essential analytical techniques for characterization and evaluation of materials generated during multi-particulate platform formulation development and polymer film coating studies.
Commitment to the team's effort resulted in successful completion of multi-particulate platform formulation and process development.
Gained expertise in Near Infrared (NIR) Spectroscopy and led successful departmental initiative to develop a method to measure moisture of tablets within a sealed system.
This technique allowed for rapid, non-destructive headspace moisture analysis, replacing the labor-intensive Karl Fischer titration method.
Assumed status of building radioactive permit holder; duties involved laboratory training of personnel, decontamination of laboratory instruments and surfaces, and accurate inventory of radiolabeled material.
Chemist, Merck Research Labs.
10/2002 － 12/2004
Ensured that assigned release, stability, and experimental samples were tested and documented in compliance with GMP regulation and standard operating procedures.
Assisted in development, validation, and optimization of analytical methods for several early phase compounds.
Participated in team meetings and provided written summaries of relevant data to management and project team members.
Performed GMP second chemist review for multiple projects within the department.
Gained expertise in several analytical techniques, such as NIR spectroscopy, particle size measurement, microscopy, particulate determination, Laser Induced Breakdown Spectroscopy, and Inductively Coupled Plasma.
Regular Member, American Chemical Society, January 2003 - Present