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Associate Director, Regulatory Affairs

APP Consultants Cranbury, NJ Full-Time
$90,000.00 - $165,000.00 / year
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The Associate Director, Global Regulatory Affairs is responsible for providing expertise and leadership to obtain marketing approvals outside the U.S. for company brand products. Activities include, but not limited to: developing, directing, defining and implementing strategies and best practices for the submission and maintenance of high quality and complete Clinical Trial Applications (CTAs), Marketing Authorization Applications (MAAs) and Drug Master Files (DMFs), etc.

The incumbent functions independently as a decision-maker and subject-matter expert (SME), while working collaboratively with key internal and external stakeholders, to prepare high-quality submissions that meet the requirements of various Health Authorities (HAs) outside the U.S.

Bachelors degree AND minimum 6 years related quality and/or compliance experience in the pharmaceutical or biotechnology industry in positions of increasing technical responsibility OR a combination of education and 9 years related quality and/or compliance experience in the pharmaceutical or biotechnology industry in positions of increasing technical responsibility.

Recommended skills

Decision Making
Authorization (Computing)
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