Associate Director, Late-Stage Drug Product Development
Job in
Montgomery, Montgomery County, Alabama, 36136, USA
Listed on 2026-07-10
Listing for:
Otsuka America Pharmaceutical Inc.
Full Time
position Listed on 2026-07-10
Job specializations:
-
Pharmaceutical
Pharmaceutical Manufacturing, Regulatory Compliance Specialist -
Management
Regulatory Compliance Specialist
Job Description & How to Apply Below
Otsuka America Pharmaceutical Inc. seeks an Associate Director, Drug Product & Process Development to lead late-stage development from Phase 2/3 through commercialization.
You will oversee formulation optimization, process validation readiness, and robustness studies while guiding tech transfer and scale-up for commercial manufacturing. You will serve as the CMC lead for NDA/MAA filings, interface with global health authorities, and ensure alignment with QbD and regulatory expectations.
#J-18808-LjbffrPosition Requirements
10+ Years
work experience
To View & Apply for jobs on this site that accept applications from your location or country, tap the button below to make a Search.
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
Search for further Jobs Here:
×