Analytical Development Director, Small Molecules NDA

Otsuka Pharmaceutical Co., Ltd; Princeton (NJ); On-site; USD 169,000 - 253,000; Full time

Benefits offered by this job

Medical Insurance

401(k) Match

Paid Holidays

Job summary

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

Qualifications

• PhD in Analytical Chemistry or related field; or MS with extensive relevant industry experience.
• 12–15+ years of pharma/biotech experience in small-molecule analytical development and NDA submission readiness.
• Proven leadership of programs from early development through NDA filing and regulatory engagement.

Responsibilities

• Lead portfolio-level analytical strategy and governance for small-molecule programs across development to commercialization.
• Own NDA analytical narrative and regulatory interactions with FDA and Health Authorities.
• Provide analytical risk assessments and lifecycle planning for methods, stability, and impurities.
• Lead CDMO/CRO governance, vendor selection, and outsourcing strategy for NDA-defensible analytical work.
• Partner with Regulatory Affairs, Quality, Process Chemistry, MSAT, and Supply Chain to influence CMC timelines.

Skills

Analytical Development

Small Molecules

Regulatory Strategy

NDA Experience

Leadership

FDA Interactions

Education

PhD in Analytical Chemistry

MS in related field

Tools

HPLC/UPLC

GC

XRPD

DSC

TGA

ICH Guidance

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