New job Associate Director - PRC, Regulatory Affairs(Pharma) -Malvern,PA

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Group: Job Openings, Job Leads and Job Connections! Subject: Associate Director - PRC, Regulatory Affairs(Pharma) -Malvern,PA Robert Ciociola posted a job: Associate Director - PRC, Regulatory Affairs(Pharma) -Malvern,PA "Send resumes to: bciociola@covexllc.com The Associate Director - PRC, Regulatory Affairs US, is primarily responsible for regulatory affairs representation on Promotional Review Committees for company products marketed in the US and Canada. The Associate Director - PRC At least 10 years pharmaceutical industry experience (preferably within a small to mid-sized company) with at least 6 years experience in regulatory affairs including 5 years experience representing regulatory affairs in promotional review for FDA-regulated drugs and/or therapeutic biologics; previous experience at or above Manager level in RA • provides expert advice on compliance with applicable laws, regulations and regulatory precedence • works with Marketing to assure that internal procedures for time-of-first-use submissions to DDMAC are followed • prepares requests for DDMAC comments • acts as a liaison with DDMAC • stays current on changes in the regulatory landscape related to promotional activities for company products 1. Manage all assigned regulatory projects; determine submission requirements and manage all relevant processes; may act as liaison to FDA and Health Canada for Company 2. Work with supervisor to develop Regulatory strategy/plans for all assigned drug development projects 3. Identify, implement and manage PRC-related electronic document control system, if applicable. 4. Provide regulatory consultation to other departments, i.e., provide regulatory advice, based on solid understanding of current FDA regulations/guidances and practices. 5. Monitor the effect that proposed changes in FDA regulations may have on current and future development strategies   Bachelor’s degree or above in a related scientific field strongly desired  Demonstrated training and independent experience in promotional review  Direct contribution to regulatory submissions required"

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