Vacancy caducado!
Regulatory Operations Submissions Specialist - 12+ month Contract Location: Greater Philadelphia, PA (Conshohocken) or Greater D.C. Metro Area (Rockville) We are working with a leading Biotechnology company focused on the creation and development of innovative and differentiated T Cell Receptor products, with the aim of improving the lives of cancer and autoimmune disease patients.This company has a strong pipeline of products in collaboration with some of the most notable Pharma/ Biotech companies across the globe. They are seeking a Submission Specialist to support the Regulatory Operations team. Ideally this person will have experience preparing various submissions (IND, NDA, BLA, CTA, MAA, etc) for the US FDA and other global Health Authorities. This person will also play a part in the implementation and maintenance of a new Regulatory Information System (RIM). Responsibilities include:
- Support Regulatory Affairs team, Vendors, CRO's, and cross functional teams by preparing Regulatory Submissions and managing tasks contracted to vedors
- Assessment and implementation of SOP's and process improvements
- Assist in the implementation of an Electronic Document Repository and Regulatory Information Management System
- Ability to work on multiple projects, while maintaining quality and timelines, and able to prioritize workload with minimal supervision
- Health insurance
- Casual Dress code
- 401k match