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This position has the responsibility for supporting the Regulatory Affairs (Pharma) department in developing and executing regulatory strategies primarily on drug-device combination products, or prescription pharmaceuticals. Position is also responsible for the on-time filing of high-quality regulatory submissions for new products and for post-approval maintenance of regulatory dossiers. The position interacts with all levels in the organization.  The Sr. Manager may interface with regulatory agencies, primarily the FDA and EMA, as it relates to submissions and other relevant topics. PROVIDE STRATEGIC REGULATORY GUIDANCE TO MANAGEMENT AND INTER-DISCIPLINARY PROJECT TEAMS ·