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Senior Regulatory Affairs Associate

Location: FL
Industry: Pharmaceutical
Job Code: 12024-05

Description:

Coordinate the compilation of documents needed to file a BLA/SMF/IND to the FDA and obtain approval. Coordinate post-approval supplements and annual reports to an application as needed due to changes in Clinical, Non-clinical, Chemistry and Manufacturing Controls, labeling, etc.  Assist in the preparation and submission of INDs, BLAs, and Orphan Drug and Fast Track applications to regulatory agencies. Fulfill post approval requirements by coordination the submission of annual reports and appropriate supplements. 

Requirements:

• Five years of regulatory affairs experience within a in a biologics environment.

• BS level degree in health or science related discipline.

 

Contact:

For more information on this or any of our other available positions or to be contacted by one of our staffing specialists, please send us your resume, cover letter and RegExec job code to resume@regexec.com.

PLEASE NOTE: All resumes that are received by RegExec will be thoroughly reviewed by one of our staffing specialists and treated confidentially.