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CMC Regulatory Affairs Specialist
Ref No.: 18-00586
Location: Research Triangle Park, North Carolina
Position Type:Contract
Start Date: 05/01/2018
CMC REGULATORY AFFAIRS SPECIALIST
RESEARCH TRIANGLE PARK, NC


Project Description:
Preparation of high quality chemistry, manufacturing and control (CMC) regulatory documents for new, small molecule products, using varied information sources and liaising closely with other Client personnel to ensure accuracy of such records. Work to agreed deadlines, with ability to respond readily to changing events and priorities.

Required Skills:
  • CMC Regulatory Affairs experience; planning, authoring, reviewing and project management of regulatory submissions.
  • Good written and oral communication.
  • Demonstrated ability to focus, work with attention to detail and retain critical information.
  • Demonstrated team working skills, with the ability to establish strong relationships and liaise effectively with Client sites worldwide.
  • Demonstrated effective time management skills.
  • Be proficient in the use of IT packages such as Word, Excel and Documentum systems.
  • Demonstrated problem solving skills.
  • Degree in Pharmacy, Chemistry or related discipline.

Preferred experience:
  • Global experience, (including EU, US, Japan and emerging markets), in the following types of CMC submissions:
  • Clinical trials documents
  • Marketing applications for new medicines and managing the related responses to questions.
  • Post approval variations.

This 5+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Cindi: cindip@alphaconsulting.com

ALPHA'S REQUIREMENT #18-00586
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE