, for each other, and for the future of science, we're in. Are you? About the Role: The Associate Director, Regulatory Affairs, CMC... will be responsible for reviewing the CMC post approval changes, providing regulatory impact assessments, and coordinating with regional...
on , , , , and . Job Description The Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with internal and external... CMC regulatory affairs on teams such as the product development, Global Regulatory Product Teams and Operations brand...
on , , , , and . Job Description The Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with internal and external... CMC regulatory affairs on teams such as the product development, Global Regulatory Product Teams and Operations brand...
on , , , , and . Job Description The Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with internal and external... within the Regulatory Affairs functional areas, Operations and Research & Development (R&D) organizations. Represents CMC...
on , , , , and . Job Description The Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with internal and external... within the Regulatory Affairs functional areas, Operations and Research & Development (R&D) organizations. Represents CMC...
Job Description General Summary: The Associate Director, CMC Regulatory Affairs, Biologics executes multi-product... global regulatory CMC strategies for investigational and marketed products, with a focus on biologics. This role leads the...
Reporting to the Senior Manager, Regulatory Affairs, the Regulatory Affairs Associate will have solid experience... within CMC to aid in the development of the RA needs and support the Director with current programs. This role assists...
Associate Director, Regulatory Affairs Biosimilar/BLA Description: Regulatory expert in the area of Biosimilar/BLA... Strategies: Formulate and lead global CMC and clinical regulatory strategies for Biologics, Biosimilars, and Small Molecules...
Associate Director, Regulatory Affairs Biosimilar/BLA Description: Regulatory expert in the area of Biosimilar/BLA... Strategies: Formulate and lead global CMC and clinical regulatory strategies for Biologics, Biosimilars, and Small Molecules...
to Associate Director, Regulatory Affairs, to manage our regulatory clinical trial applications (CTAs) and compliance efforts... function of Regulatory Affairs. This role will require a minimum of 3 days a week of onsite presence (or more as business needs...
worldwide. Could you be our next Associate Director Global Regulatory Lead, EHT (Enabling Healthcare Technologies encompasses.... You will report to the Executive Director Head Regulatory. Position Description Summary Regulatory leaders who develop a global...
and diverse backgrounds are connected. The Sr. Manager/Associate Director, Regulatory Strategy, will be responsible for day... with Regulatory CMC and Regulatory Operations to ensure EyePoint’s submissions meet global regulatory requirements. This position...
Technical Writing or Regulatory Affairs, CMC. Nuanced understanding of regulatory risk and ability to develop risk mitigation... (Metrics and KPIs) to drive excellence in Regulatory CMC pre- and post-submission activities. Collaborates across RA CMC...
Management (RIM) / Regulatory Operations Position Summary The Associate Director, Process Business Analyst & Documentation... Director, Process Business Analyst & Documentation - Veeva Vault RIM Location: Remote Department: Regulatory Information...
, for each other, and for the future of science, we're in. Are you? About the Role: The Associate Director, Quality Control will be responsible... requirements. Contribute QC content for regulatory filings (IND, NDA, BLA), and collaborate with Regulatory Affairs to prepare high...
on , , , , and . Job Description The ME&C Associate Director is a global program management expert responsible for managing major global programs... their broad understanding of Product Development, Manufacturing, Quality and Regulatory Affairs to translate the business...
on , , , , and . Job Description The ME&C Associate Director is a global program management expert responsible for managing major global programs... their broad understanding of Product Development, Manufacturing, Quality and Regulatory Affairs to translate the business...
(Associate Director) - Global Manufacturing Science GMSci Drug Product (DP), you will provide technical expertise within the... Regulatory Affairs. SME for Takeda drug product manufacturing organization and network. In depth and broad understanding...
Associate Director, Small Molecule Analytical Development Lead and oversee phase appropriate method development.... Collaborate cross-functionally with analytical team members, process chemistry, formulation development, regulatory affairs...
-regulatory Affairs, while serving as an important point of technical contact between Eidos and contract manufacturing... drug product disposition. You will also work with colleagues in CMC, Supply Chain Operations, Quality Assurance, and CMC...