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Director of Global Drug Regulatory Affairs

bullet VP, Process Analytical Technology/Dosage Forms $200,000 plus
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Assoc Director or Manager of Reg Affairs

bullet Mgr, Process Engineering, NE $100K plus
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Assoc Director, DRA - oncology or ophthalmology

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Director, A/D of Subm Compliance and Info Mgt

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Director of Global Drug Regulatory Affairs, Strategy and Liaison

Major pharma in NE USA, global drug regulatory affairs position, working primarily with marketed products across a wide spectrum of therapeutic areas. Salary in the $135-165K range, plus bonus, stocks, etc. Full relo available.

Assoc Director or Manager of Reg Affairs, Strategy and Liaison

Major pharma, job duties: to handle primarily early development drug regulatory affairs (IND and NDA), strategy, and FDA and ex-US liaison. The successful candidate will work 60-80% with CNS drugs, though CNS experience is not a prerequisite. BS or better. Full relo and generous compensation package to the successful candidate.

Associate Director, Drug Reg Affairs - oncology or ophthalmology (small molecules)

Major pharma in southern California. Full gamut, from developmental to marketed products, emphasizing clinical/pre-clinical parts of submissions, regulatory strategy and liaison. Oncology or ophthalmology experience highly desired. BS or better in science, and drug regulatory experience necessary. Generous compensation package and full relo available.

Director or A/D of Submissions Compliance and Info Mgt

Major pharma, NE USA, looking for an innovative, creative leader who possesses technical knowledge regarding electronic submissions and, equally as important, possesses the ability to lead and manage people in a pharmaceutical regulatory environment. The successful candidate will manage 3 global submissions managers and 1 e-submissions technology lead (who interfaces between the IT group and the submissions producers).

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VP, Process Analytical Technology/Dosage Forms $200,000 plus

Client Company is recruiting candidate with extensive technical knowledge in dosage forms including steriles, and liquids, creams and ointments. This role will provide strategic technical direction in bridging research and development into manufacturing efficiencies. The individual will partner with R&D through effective alliance to identify, evaluate and implement new technologies to add value through dosage form design to new products. For immediate and confidential consideration, please send resume to Julie or call her at 800/905-6884.

Mgr, Process Engineering – Northeast $100,000 plus

10 plus years of process design in pharmaceutical or biotech manufacturing environment needed to execute technical process projects as well as lead a small group of process engineers. Must have thorough knowledge of unit operations, GMP’s, and excellent leadership/interpersonal skills. For immediate and confidential consideration, please send resume to Julie or call her at 800/905-6884.

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