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Senior Manager of Regulatory Affairs, Pharmaceutical

MRINetwork Jobs Independence, KS

  • Expired: over a month ago. Applications are no longer accepted.
Job Description

Our client is an exciting Medical Technology and Pharma company with 20+ years of growth, first to market technology, and an exciting product pipeline.  We are supporting them for a Senior Manager of Regulatory Affairs that will develop and execute on regulatory strategies for drug-device combination products and prescription pharmaceuticals.  This leader will be responsible for regulatory submissions for new products and post-approval maintenance or regulatory dossiers while having interfacing responsibilities with the FDA, EM, and governing bodies.

The Right Talent:

BS Degree in a Scientific Discipline preferred

7+ Years of Pharma experience with 4+ supporting the development of regulatory submissions: NDA, IND, Amendments, CTAs, IMPD, etc.  

Knowledge of regulatory requirements throughout clinical/drug development & lifecycle management

Experience with the FDA and governing bodies

Experience with the review & submission of labeling and promotional materials preferred

Experience with Pharmacovigilance post-marketing a plus

 

Opportunity for a hybrid/remote and travel role

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Address

Independence, KS
USA

Industry

Government

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