The Associate Director (AD) of Regulatory Operations is responsible for assisting the Head of Regulatory Operations in maintaining the company's regulatory submission standards and current electronic submission guidelines/requirements. Th...
The Senior Manager/AD, Regulatory Affairs serves as a Health Authority liaison and key member of project teams, establishes and communicates regulatory strategies for development programs, and coordinates the timelines, generation, and subm...
This role requires excellent written communication, grammar, and investigative leadership skills. Candidates should be detail-oriented, proactive, and able to navigate shifting priorities in a fast-paced environment with minimal oversight. ...
Our client is looking to add a Statistical Programmer Consultant to their team on a contract basis. Responsibilities: Involved in the programming activities on multiple projects/ studies across various therapeutic areas, both internally...
In this critical role for the Thousand Oaks Drug Product (DP) facility, you will be responsible for the introduction of new products into the manufacturing plant. This “Specialist Manufacturing” role will serve as a New Product Introductio...
Responsibilities Under minimal supervision, the successful candidate will support the QC organization by: Conduct analytical testing, in accordance with SOPÂ’s, to characterize various substances and materials. Perform variety of assays a...
The Quality Microbial Control Analyst will act as a team member of the Quality Microbial Control department to support production of in-process and final product drug lots for customers. Also participate in quality testing for ongoing custo...
The Director, Clinical Data Management (CDM) is responsible for oversight, execution, and quality of all data management activities across assigned clinical trials from study start-up through database lock. This role ensures the integrity, ...
Position supports global logistics and distribution of drug substance, drug products and finished goods in cooperation with internal and external partners. The role requires an in depth understanding of GXP, Veeva Quality Management System,...
The Pre-Pivotal Drug Substance Technologies organization at our client develops, characterizes and supports clinical drug substance manufacturing processes for all early-stage programs in the company portfolio. The Pivotal Drug Substance ...