Laura G. Cristea

  • Lynchburg VA 24502, USA

Work History

Work History
Sep 2006 - Dec 2014

Research Assistant

Chemistry Department, Ohio University, Athens, USA
  • Design of six molecular constructs to characterize hydroxyproline-rich glycoprotein modules
  • Utilization of molecular techniques to clone DNA constructs
  • Purification of RNA and protein for expression analysis Agrobacterium transformation on tissue and suspension culture
  • Over expression and recovery of recombinant proteins
  • Biochemical characterization of transgenic glycoproteins
  • Antibody design for protein identification and isolation
May 2004 - Aug 2006

Regulatory Affairs Associate

Geneva Romfarm International, Bucharest, Romania
  • Coordination of regulatory affairs activities for a portfolio of 25 products  
  • Preparation and submission of the updated scientific documentation for EU accession
  • Emergency drug approval for a special patient case
  • Informal/formal training of the medical sales representatives
  • Submission of documentation for drugs' price and reimbursement
  • Identification of potential market niches addressing unmet medical needs with recommendation of Actelion Pharmaceuticals & Amgen
  • Contributions to the in vitro fertilization legislation draft
  • Direct liaison between regulatory authorities and Swiss drugmakers
Apr 2002 - Apr 2004

Regulatory Affairs Associate

Ranbaxy Laboratories Limited, Bucharest, Romania
  • Coordination of regulatory affairs activities for more than 30 products
  • Preparation and submission of products applications, renewals, updates and variations
  • Patent management
  • Market research of competition patents and licenses
  • Direct liaison between regulatory authorities, Ranbaxy's regulatory headquarters and clients

Education

Education

Skills

Skills

reimbursement

Utilization

regulatory authorities

Competition

GENEVA

Certifications

Certifications

Medical Devices and Pharmaceuticals (Dual), Certificate of Course Completion

Regulatory Affairs Professionals Society
US Legislation for Medical Devices and Pharmaceuticals