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Associate Director - Regulatory Submissions (ANDA)

Company Name: Company Confidential through FPC of Raleigh
Location: Irvine, CA
Job Type: Full-time, permanent
Contact Name: Joanne Gehas, Ph.D.
Phone: 
Fax:
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.
Salary: Up to 135K base and bonus

Job Description

A mid-size and growing pharmaceutical company developing their own products (mainly ANDA, but some NDA) who also has approved products is seeking a hands-on leader who can manage and drive regulatory submissions (mainly ANDA). 

The role would report into a VP level and be responsible for 

- providing regulatory input and strategy during the development of regulatory submission documentation 

- review all portions of regulatory submissions (includes, but not limited to CMC documentation, clinical and non-clinical) 

- provide leadership to regulatory department to improve systems internally and coordination between regulatory associates at multiple sites across the US 

- deliver effectively presentations and represent Regulatory Affairs at project team meetings

Job Requirements

BS/MS Scientific degree preferred 

Strong understand of the drug development process (ANDA/NDA) 

CMC background preferred 

10+ years of pharmaceutical industry experience 

5+ years of Regulatory Submissions (ANDA preferred, ANDA and NDA a plus) experience - experienced in filing and maintaining ANDAs 

Excellent verbal and written communication skills