Scientific and educational background (B.Sc. Or MSc) to understand pharmaceutical drug development concepts, regulatory concepts and create documentation based on these concepts .
Comprehensive understanding of regulations and guidelines to enhance probability of regulatory success and regulatory compliance .
Excellent project management skills .
Experience in regulatory submissions roles, supporting the compilation of module 3 components of a submission, related Quality/CMC documents and components, and regulatory briefing documents .
Good writing skills for technical writing .
Detail oriented and highly organized .
Good verbal communication skills for leading meetings and remote interactions .
Work well in team setting on a fast-paced business critical project .
Excellent oral and written communication skills for effectively interfacing with higher levels of management and departments within the company .
Support BLA/MAA/ROW (emerging markets) expansion effort for a biologics project, including compilation of market-specific requirements and leading information request response preparation .
Track submission activities and change controls for RACMC and ensure visibility to cross-functional CMC stakeholders .
Assist with ongoing GXP systems transition, related to change control and regulatory dossiers .
Ad hoc RACMC support to line manager .
Assist with post-approval and investigational life cycle management as needed, including but not limited to post approval supplements and variations, annual reports, and investigational (IND/IMPD) amendments, per team and program timelines.
The outlined tasks may be subject to change as the workload of the business requires .
This 12+ month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Jim: jim@alphaconsulting.Com
ALPHA'S REQUIREMENT #22-02368
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE