Project 55157 – US FDA BLA submission



pharmatch

JOB DESCRIPTION

Contract Type

Candidate (Freelancer)

Company Type

Consulting / CRO

Company Size

Big > 5000


Requested Expertise

Regulatory Affairs / Clinical study / Clinical development /

Profile Required

– English fluent
– Regulatory affairs background and expertise
– >7 years of actual experience in BLA and IND submissions for USFDA and other relevant regions

Project Description

Regulatory dossier preparation of a BLA for USFDA.

Therapeutic Area

All

Language

English

Hard Skills

Regulatory Dossier,Fluency in English

Soft Skills

Assertiveness

Seniority Level

Experience 5 – 10 years,Experience > 10 years


Starting Date

2023-06-01

Project Duration

3 months

FTE / nb of days per week

5

Project Location

Remote, United States of America

Remote Flexibility

Yes

Travel Expected

No

Approximative Budget

Any other information of interest

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