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.
Planning, authoring, reviewing and project management of regulatory submissions.
Degree in Pharmacy, Chemistry, or related discipline.
CMC Regulatory Affairs experience.
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.
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 #22-02416
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE