Job Number: 20846995
CMC REGULATORY AFFAIRS EXECUTIVE
100% Remote or local candidate.
- 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.
- 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