Joulé

Compensation

Full Description

Regulatory Submission Project Management Specialist Location: Remote Term: 12-month renewable (CONTRACT TO HIRE) Target Pay: $30-$36/HR Must have recent PHARMA regulatory experience, preferably working on submissions. The Temp Regulatory Submission Project Management will provide support to the Regulatory Submission Management (Reg SM) group by working on routine regulatory submissions, responsible for tracking deadlines for various regulatory obligations, and assist with submission work for major submissions such as INDs, CTAs, BLAs and supplements, MAAs and variations. A typical day may include: • Schedules and manages routine regulatory submissions, such as those for IND safety reports, clinical site documentation updates (1572s), lot releases, promotional pieces • Provides support for monitoring and tracking performance of submission process for clinical site documentation (Form FDA 1572) • Coordinates publications (literature references) for submissions across all programs • Tracks submission deliverables for routine submissions, and provides support in tracking deliverables for larger submissions • Manages overall completeness of scheduled submissions and coordinates with Regulatory Operations on submission timing, and document status This role could be for you if you have: • Strong knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc). • experience with eCTD knowledge. • Experience in submission processes and systems • Ability to work with firm deadlines and adapt quickly to changing priorities • Expertise in document management • Strong knowledge with MS Office applications, Adobe Acrobat, electronic document management systems (eDMS) required. To be considered for this role, you must have a Bachelor’s Degree with 0-2 years of relevant industry experience. Ref: #568-Clinical