Regulatory Affairs Director, Assoc. Director, Manager, Trainer

Regulatory Affairs positions in Central NJ and Philadelphia

1.Regulatory Affairs Associate Director. BS or advanced degree inscientific / life sciences. 8-10 years pharmaceutical industry experience and 5 years direct regulatory affairs. Central NJ.

2.Regulatory Affairs Manager. Minimum of 3-5 years previous experience in Regulatory Affairs within a pharmaceutical environment. IND/NDA/sNDA submission/post-approval experience. Central NJ.

3.Regulatory Affairs Training. 12-15 years pharmaceutical regulatory affairs and formal training experience required. Central NJ.

4.Assistant Director Regulatory Affairs Liaison. Direct the preparation and submission of INDs, NDAs, reports and correspondence to the appropriate regulatory agencies for assigned projects. Demonstrated knowledge of drug development process is essential. Knowledge of laws and regulations affecting the pharmaceutical industry, and regulatory experience. Central NJ.

5.Director / Project Leader - Regulatory Affairs Liaison. The Regulatory Project Leader (RPL) is part of the Regulatory Development team, and works closely with the Therapeutic Axis Head (TAH) to provide input for development of global strategies and implementation as an integral part of the therapeutic axis management team. Degrees: MD, Ph.D., MS. Central NJ.

6. Senior Regulatory Affairs Specialist. Responsible for supervising various aspects of the Regulatory Compliance group including FDA registration activities, DEA registration activities, FDA DMF Updates and Referrals, DEA Purchase, Sales and Exporting Activities, Global Trade Compliance Officer duties, Foreign regulatory activities and participation on multi-functional task teams as required. Philadelphia, PA.
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