Senior Manager of Regulatory Affairs, Pharmaceutical
MRINetwork Jobs Independence, KS
- Expired: over a month ago. Applications are no longer accepted.
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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