Regulatory Affairs Specialist (100% Remote WFH)
6+ Month Contract
$40-50/HR Based on Years of Experience (8+ years of experience firm for principal level)
There are currently 20 openings. These are 100% Remote Contracting Opportunities paying $40-50/HR. These are URGENT needs and will be interviewing and hiring ASAP.
Provides innovative solutions including regulatory expertise and client interface to provide strategic intelligence, and guidance supporting product development from preclinical through registration and product optimization. Provides strategic, expedient and efficient preparation of client deliverables that meet current local, regional and ICH regulatory and technical requirements. Acts as liaison with internal and external clients in the provision and marketing of these services.
· -- Regulatory knowledge of global post-approval submissions – variations/line extensions/renewals, etc.
· -- Ability to prioritize and manage multiple projects
-K- Knowledge of RIMS document management systems and particularly Veeva vault a benefit.
· Supports the preparation of documentation and submissions under guidance.
· Coordinates and manages client deliverables supporting regulatory compliance.
· Liaises with internal and external clients in the tracking and status update of project plans and overall support of projects.
· Assists with project budgeting/forecasting.
· Maintains knowledge and understanding of SOPs, client SOPs/directives, and current regulatory guidelines.
· Assists in business development and pricing of projects for the department.
· Evaluates client needs in relationship to overall project timelines, quality and delivery.
· Engages other project team members, functional units and/or management as necessary to deliver final product, and resolve/mitigate identified issues or
barriers to delivery as needed.