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and communication with Therapeutic Area Regulatory Affairs (Global Regulatory Leader), project Compound ... and appropriately escalates issues to CMC Regulatory Affairs Management that affect registration, regulatory...
CMC Regulatory Affairs Manager Requisition ID: 83850 Position: Full-Time Regular Open date: Apr 19, 2013 6:05:08 PM ... multiple projects/teams. Continued professional growth in regulatory affairs, including communication of evolving...
products that range from medical to aviation is seeking a Regulatory Affairs Specialist. The RA Specialist will help ... with the development, implementation and maintenance of regulatory SOP's Participate in continuous (breakthrough)...
Regulatory Affairs Manager The Group Manager, Regulatory Affairs, is responsible for writing, submitting and gaining ... or equivalent.? Minimum of 3 years experience in Regulatory Affairs in medical device industry, or equivalent.?...
will include: Evaluate change controls and provide final regulatory assessment. Review ANDAs, Amendments, ... pharmaceutical industry experience and at least 2 years regulatory affairs experience Supervisory experience...
Partial Job Description 1) Conduct regulatory reviews of technical summaries, clinical study reports and administrative ... with clients regarding regulatory issues 7) Conduct regulatory reviews for eCTD/electronic submission...
and communication with Therapeutic Area Regulatory Affairs (Global Regulatory Leader), project Compound ... and appropriately escalates issues to CMC Regulatory Affairs Management that affect registration, regulatory...
Affairs Division Orthobiologics Business Functions Regulatory Affairs Business Sub-Functions Regulatory Affairs ... for regulatory impact. .Prepare and manage budget for the Regulatory Affairs department. .Participate in continuous...
managers and CMC reviewers to facilitate approval of regulatory submissions and coordinates responses to Health ... Authorities. 5) Represents regulatory CMC and provides US regulatory filing strategy recommendations to...
include, but are not limited to: Managing a staff of 5+ Regulatory Affairs Engineers in a Class 3 PMA medical device ... International. Manage the preparation and submission of all regulatory submissions for device approvals and...
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