Job at a glance
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 RA CMC 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. Required Skills Scientific and educational background (BSc 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. 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. Excellent project management skills. 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. This 6+month position starts ASAP. Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: [email protected] ALPHA'S REQUIREMENT #23-01064 MUST BE ELIGIBLE TO WORK IN THE U.S.
AS AN HOURLY W2 EMPLOYEE Looking for remote jobs near your area? At Yulys, thousands of employers are looking for exceptional talent like yours. Find your perfect fit now.