Regulatory Operations Submission Specialist - month contract job vacancy

Vacancy expired!

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

For further information and full job description please apply with an updated resume.

Consultant Information:

Nicole Lyons - Senior Recruiter - Regulatory Affairs

T: +1 315.506.5449

Benefits:

Health insurance
Casual Dress code
401k match

Make the best career decision ever. Send us your resume.

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Vacancy expired!

ID	#15369429
State	Pennsylvania
City	Philadelphia
Job type	Contract
Salary	USD $30 - $45 per hour 30 - 45 per hour
Source	Real Staffing
Showed	2021-06-12
Date	2021-06-12
Deadline	2021-08-11
Category	Et cetera
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Job Details

Regulatory Operations Submission Specialist - 12 month contract

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