Itasca, TX
... Assisted with FDA submissions, updated clinical trials data spreadsheets, updated procedures manuals, and assisted with delivery of PMA Module submission. Highland Homes Exec Admin Asst to President & CFO July 2014 - February 2016 Liaison for staff ...
- Oct 13
Middletown, DE
... BRYANT Tasha.bryant@ fda.hhs.gov *******@*****.*** *** ********** ****. ******, ** 19711 302-***-**** OVERVIEW Forward thinking, flexible individual with advanced knowledge of human resource principles and ability to professionally handle any human ...
- Oct 13
Palmdale, CA
... equipment and service agreement for internal use •Collaborate with internal Customers (A/P, Quality, Receiving/Shipping, Engineers) and external customers (Vendors, subcontractors and consultants) •Adhere to regulatory requirements (FDA, TUV,etc. ...
- Oct 11
Pune, Maharashtra, India
... FDA Query Analysis related to methods. Method verification of new pharmacopeial methods. Analysis of Routine Formulation Batches of Tablets, Capsules, Powders for oral suspensions Oral solutions and Oral suspensions received from F&D for regulated ...
- Oct 11
Visakhapatnam, Andhra Pradesh, India
... Audits FDA, MHRA, WHO, TGA, Customer audits (TEVA, LUPIN, SUN PHARMA, Breckenridge) Internal audit and GMP audit. Qualification S.S.C 2005 From Board Secondary Education AP. Diploma(Mechanical) 2008 From A.I.I.T. Intermediate 2021 from open school ...
- Oct 11
Los Angeles, CA
... Quality Assurance • Order entry (2 years) • Cycling (2 years) • Word processing (7 years) • Personal assistant experience • FDA regulations • Medical billing • First aid • Bilingual • SKILLS Fluently Bilingual English/Spanish Type 50 WPM Data Entr y ...
- Oct 10
Garner, NC, 27529
... Proven track record in preparing, compiling, and submitting eCTD-compliant regulatory dossiers, including INDs, NDAs, BLAs, ANDAs, and IMPDs across multiple regions (FDA, EMA, Health Canada, and MHRA) in alignment with ICH, FDA, and regional ...
- Oct 10
Raleigh, NC
... • Partnered with global teams to ensure FDA/QSR/GMP compliance and drive continuous improvement. • Developed vendor qualification and review processes to align external partnerships with regulatory expectations. • Facilitated internal and external ...
- Oct 10
Edgemere, MD, 21219
... Skilled in regulatory compliance (CLIA, FDA, OSHA, AGES, EMA, PPTA), supplier quality management, CAPA and risk management. Adept in cross functional collaboration, team leadership and inspection readiness. Committed to maintaining high product ...
- Oct 10
Pune, Maharashtra, India
... "Completed PG Diploma in Clinical Research with knowledge of drug development, clinical trial design, regulatory guidelines (ICH-GCP, FDA, CDSCO), pharmacovigilance, and data management." "Trained in clinical pharmacology, rational drug therapy, ...
- Oct 10