CMC Regulatory Affairs Executive

Durham, NC

Posted: 06/22/2022 Job Number: 20846995

Job Description

CMC REGULATORY AFFAIRS EXECUTIVE
DURHAM, NC
100% Remote or local candidate.

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 company personnel to ensure accuracy of such records.
  • Work to agreed deadlines, with ability to respond readily to changing events and priorities.

Required Skills:
  • Degree in Pharmacy, Chemistry, or related discipline.
  • Min. 1yr experience in CMC Regulatory essential .
  • 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 company sites worldwide.
  • Demonstrated effective time management skills.
  • Be proficient in the use of IT packages such as Word, Excel and Veeva Vault systems.
  • Demonstrated problem solving skills.
  • 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 12+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Angie: angie@alphaconsulting.Com

ALPHA' S REQUIREMENT #22-01948
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE

Meet Your Recruiter

Angie Dawn

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