Search Jobs: Results: Associate Director - Regulatory Affairs Submissions

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

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

 

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

 


Job Details

Name:   Joanne Gehas   Date Posted:   06/16/2017
Office:   Raleigh   Telephone:   (919) 760-3005
Email:   jgehas@fpcraleigh.com   Fax:   (919) 848-1062
Industry:   Pharmaceutical
Function:   Regulatory Affairs, ...»   Sub Category:   Strategist, ...»
Keywords:   ANDA, submissions, FDA, 505(b)2   Region:  
State:   California   City:   Irvine
Education:   BS   Job Number:   J53939-RALE

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