Gladys Martin Email and Phone Number
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Qualified by professional history in Regulatory Affairs, Chemistry, and a Bachelor's degree in Chemistry with specialization in the following skills:-Pharmaceuticals and Medical Devices Labeling Regulations expert-ANDA and NDA submissions regulations-Advertising and Promotional labeling regulations-Management, supervision, leadership and training -Due diligence of new products-Working knowledge of GMP’s, GCP’s-Project ManagementSpecialties: -Pharmaceutical, Dietary Supplement, OTC drugs and Medical Device Product Labeling, and Advertising/Promotional Labeling-Federal and State registration requirements-Document and labeling Translations (English/Spanish)-Pharma and Dietary supplements GMPs, CGPs
Romark, L.C.
View- Website:
- romark.com
- Employees:
- 173
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Senior Manager Regulatory AffairsRomark, L.C. Oct 2013 - PresentTampa, Fla
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Real Estate ProfessionalKeller Williams Realty - Tampa Properties Apr 2007 - Oct 2015 -
Senior Regulatory ConsultantPharma Consulting Solutions Llc Jun 2009 - May 2010
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Contracted Regulatory Affairs ConsultantSirion Therapeutics Dec 2007 - Oct 2008Reviewed and approved Advertising and Promotional materials. Developed SOPs for Labeling and Advertising Reviews. Established an Advertising Review Committee as well as a eRoom for review and approval of documents. Reviewed labeling for new drugs. Initiated the application process for State licenses. -
Director, Regulatory AffairsBausch & Lomb Mar 2004 - Oct 2007-Supervision of one (1) executive, two (2) exempt and two (2) non-exempt employees.-Review and approval of all pharmaceuticals product advertising, dietary supplements and select medical device solutions.-Involved in the due diligence activities of new products.-Reviewed and approved clinical trial protocols for dietary supplement products, and Regulatory review and approval of documents needed for the release of clinical trial materials.-Key expert in pharmaceutical product labeling for the corporation.-Manage the labeling review, approval, and disposition process of all pharmaceutical products for domestic and international markets, including approval of clinical trial labeling.-Develop draft labeling for new generic and proprietary products.-Manage the submissions of the labeling sections for Annual Reports and Adverse Event Periodic Reports, and advertising submissions to FDA. -
Regulatory Affairs ManagerBausch & Lomb Pharmaceuticals, Inc. May 2000 - Mar 2004-Key expert in pharmaceutical product labeling for the corporation.-Manage the labeling review, approval, and disposition process of all pharmaceutical products for domestic and international markets, including approval of clinical trial labeling.-Develop draft labeling for new generic and proprietary products.-Developed databases to track labeling and advertising revisions.-Manage the submissions of the labeling sections for Annual Reports and Adverse Event Periodic Reports, and advertising submissions to FDA.-Supervision of one (1) exempt and two (2) non-exempt employees.-Manage the operation of the Regulatory Affairs Document Room.-Manage the maintenance and renewal of all state and federal licenses (2 facilities).
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Regulatory Affairs Team LeaderBausch & Lomb Pharmaceuticals, Inc. Mar 1998 - May 2000-Label Committee chairperson- Managed the labeling review, approval, and disposition process of all pharmaceutical products for domestic and international markets, including approval of clinical trial labeling.-Developed draft labeling for new generic and proprietary products.-Prepared and submitted Adverse Event Periodic Reports to FDA-Managed the Medical Affairs group for 6 months.-Reviewed and approved Adverse Event files.-Supervised three non-exempt and two exempt employees.-Regulatory support to commercial operations regarding labeling and component issues.
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Regulatory Affairs Senior SpecialistBausch & Lomb Pharmaceuticals, Inc. 1996 - Mar 1998-Label Committee chairperson – Coordinate the revision, review and approval of all labeling, advertising and promotional materials for pharmaceuticals and medical devices.-Direct liaison with FDA's DDMAC and CDER on labeling compliance related matters.-Responsible for the preparation, submission and maintenance of NDC numbers, drug listings, and state, federal and customer licenses.-Preparation of the labeling section for ANDA/AADA and 510k submissions.-Coordinated and assisted in the preparation of several ANDA submissions and an NDA submission.-Responsible for review and approval of all clinical trial protocols, study report, Informed Consent forms.-Regulatory representative in the Clinical Affairs department.-Supervised three (3) non-exempt employees.-Managed the preparation of all NDA and ANDA Annual Reports to FDA.
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Regulatory Affairs SpecialistBausch & Lomb Pharmaceuticals, Inc. Jun 1993 - 1996-Label Committee chairperson – Coordinate the revision, review and approval of all labeling, advertising and promotional materials for pharmaceuticals and medical devices.-Direct liaison with FDA's DDMAC and CDER on labeling compliance related matters.-Responsible for the preparation, submission and maintenance of NDC numbers, drug listings, and state, federal and customer licenses.-Preparation of the labeling section for ANDA/AADA and 510k submissions.-Coordinated and assisted in the preparation of several ANDA submissions and an NDA submission.-Responsible for review and approval of all clinical trial protocols, study report, Informed Consent forms.-Regulatory representative in the Clinical Affairs department.
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ScientistCritikon, A Johnson & Johnson 1980 - 1992Scientist in Materials Reserach and Process Development with responsibility in the management of the Characterization and Analytical laboratory. Developed biocompatibility testing methods, analytical and physical testing, Quality Control Procedures, SPC, GMP, inspection and measurement techniques. Managed several projects related to intravenous and cardiovascular catheters. Characterization testing of polymer materials for medical devices. Material safety requirements and developed methodology for testing and analyzing data.
Gladys Martin Skills
Gladys Martin Education Details
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Chemistry, Education -
Chamberlain High SchoolHs Diploma
Frequently Asked Questions about Gladys Martin
What company does Gladys Martin work for?
Gladys Martin works for Romark, L.c.
What is Gladys Martin's role at the current company?
Gladys Martin's current role is Senior Manager Regulatory Affairs at Romark Laboratories, L.C..
What is Gladys Martin's email address?
Gladys Martin's email address is gladys.martin@kw.com
What is Gladys Martin's direct phone number?
Gladys Martin's direct phone number is +181329*****
What schools did Gladys Martin attend?
Gladys Martin attended University Of South Florida, Chamberlain High School.
What are some of Gladys Martin's interests?
Gladys Martin has interest in Kids, Cooking, Collecting Antiques, Investing, Exercise, Electronics, Home Improvement, Gourmet Cooking, Music, The Arts.
What skills is Gladys Martin known for?
Gladys Martin has skills like Fda, Pharmaceutical Industry, Medical Devices, Quality Control, Gmp, Regulatory Affairs, Leadership, Training, Management, Real Estate, Project Management, Advertising.
Who are Gladys Martin's colleagues?
Gladys Martin's colleagues are Mark Matthews, Dawn Darby, Jonathan Zarate, Edwin J. Molina Morales, Brian Knorzer, Natalia Hernandez, Jorge Rivera.
Not the Gladys Martin you were looking for?
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Gladys Martin
Hayward, Ca -
Gladys A. Martin
Bilingual Federal Investigator: National Security Background Checks (Domestic And International) And Employment And Education Equal Opportunity. Master'S Degree In Spanish. Current T/S Clearance Eligibility.Greater Cleveland1dcsa.mil -
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