Durham Jobs

Regulatory Affairs Associate Job Description: TITLE: Regulatory Affairs Specialist DIVISION/DEPARTMENT: Regulatory ... Skills for Regulatory Affairs Associate Job: CLINICAL REGULATORY IRB SUBMISSIONS DOCUMENT TRACKING 510K...

We are recruiting for a Regulatory Affairs Professional (Manager or Director Level) with Pharmaceutical or Med Device ... Industry: Pharmaceuticals, Biologics, Medical Device, FDA, Regulatory Affairs, Submissions, 510k, NDA, CE, IND, CMC,...

interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies and ... * Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines * Ability to exercise independent...

Standard Operating Procedures (SOPs); Provide oversight to Regulatory Submissions personnel; Oversee regulatory ... accuracy and timelines; Develop and oversee processes for regulatory submissions; and Responsible for overseeing...

4/24/2012 Regulatory Associate I Position Summary The Regulatory Associate I reports to the Manager for Regulatory Services and is responsible for performing a variety of activities to ... Regulatory compliance/regulatory affairs 2...

business context. 2. Good understanding of BioScience regulatory affairs. Recognized scientific expertise and ... ability to resolve complicated technical and political regulatory matters. Strong leadership skills; able to unite...

TITLE: Regulatory Affairs Specialist DIVISION/DEPARTMENT: Regulatory Affairs PRINCIPAL OBJECTIVE OF POSITION: Includes ... of appropriate data for regulatory submissions and regulatory compliance. This includes use of appropriate...

candidate. Must-haves include: Expert knowledge global regulatory requirements and practices pertaining to clinical ... Extensive and successful experience in regulatory submissions to the US-FDA and Health Canada, EMA and other regulatory...

The Regulatory Specialist / Senior Regulatory Specialist will also participate in, or lead, regulatory submission projec ... Advisory Committee Meetings, etc., as requested. The Regulatory Specialist / Senior Regulatory Specialist will...

and maintaining the company's Quality Assurance and Regulatory Compliance program. Areas of responsibility ... system. Ensure the preparations for,and management of, regulatory agency inspections (domestic and international).