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Otsuka Pharmaceutical Co., Ltd

Analytical Development Director, Small Molecules NDA

princeton, NJ

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About this opportunity

Otsuka Pharmaceutical Co., Ltd lists this Analytical Development Director, Small Molecules NDA opportunity in princeton, New Jersey. Review the employer’s description below for duties, qualifications and application requirements.

Job description

Otsuka Pharmaceutical Co., Ltd is seeking an Associate Director of Analytical Development (Small Molecules) to lead strategy, execution, and portfolio analytics from early development through NDA submission. You will partner with Regulatory Affairs and Health Authorities to define NDA analytics and risk management.

The role requires deep expertise in stability-indicating methods, impurity control, and Q1/Q2/Q6A expectations, plus strong leadership of outside CDMOs to ensure inspection readiness

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Worksite address

princeton, NJ, 08543, US

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