Associate Director, Analytical Development — NDA Strategy

Otsuka Pharmaceutical Co., Ltd; Princeton, Northern (NJ, KY); Hybrid; USD 169,000 - 253,000; Full time

Benefits offered by this job

Comprehensive benefits

401(k) match

Tuition reimbursement

Paid time off

Job summary

Otsuka Pharmaceutical Co., Ltd is seeking an Associate Director, Analytical Development (Small Molecules) to lead strategy and execution for analytical development from early development through NDA submission and commercialization. You will define analytical control strategies, drive regulatory success, and build scalable capabilities across programs.

The role demands 12–15+ years in small molecule analytical development with NDA experience, strong ICH method knowledge, and leadership in

Qualifications

• Ph.D. in Analytical Chemistry or related field, or MS with extensive industry experience.
• 12–15+ years in small‑molecule analytical development within pharma/biotech.
• Experience leading NDA analytical strategies and Health Authority engagements.

Responsibilities

• Lead and defend analytical strategies across small molecule programs from early development to NDA submission.
• Own NDA analytical narrative, regulatory interactions, and inspection readiness.
• Manage analytical risk, method lifecycle, and post‑approval change strategies.

Skills

Analytical strategy

Regulatory interactions

Cross-functional leadership

Analytical risk management

Data interpretation

Education

Ph.D. in Analytical Chemistry or related

MS with extensive industry experience

Tools

HPLC/UPLC

GC

Dissolution

Job description

Otsuka Pharmaceutical Co., Ltd is seeking an Associate Director, Analytical Development (Small Molecules) to lead strategy and execution for analytical development from early development through NDA submission and commercialization. You will define analytical control strategies, drive regulatory success, and build scalable capabilities across programs.

The role demands 12–15+ years in small molecule analytical development with NDA experience, strong ICH method knowledge, and leadership in