· Responsible for the strategy and execution of the site-specific aspects of the preparation of CMC investigational product amendments and post-market supplements
· Organization and preparation CMC sections of IND annual reports and annual reports of minor changes for specific products
· Act as key RA CMC representative on product deviation investigation teams
· Participates in site change control teams
· Bachelor/Master's degree (Regulatory, Life Sciences, Biotechnology or related discipline)
· 5 years of direct experience
· Candidates must have GMP site experience
· Strong knowledge of and experience in CMC
· Proficient use of MS Office tools, SharePoint and strong computer aptitude.
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
Fastnet - The Talent Group
'Not Just Placers.........Partners'
The Life Science Specialists