Associate Director Regulatory Submissions
at FPC of Raleigh

Date Posted: 6/12/2017

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

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

Job Requirements

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 Snapshot

  • Employee Type: Full-Time
  • Location: Irvine, CA
  • Job Type: Pharmaceutical
  • Experience: At least 5 year(s)
  • Date Posted: 6/12/2017

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