ASSOCIATE DIRECTOR REGULATORY CMC jobs in UNITED STATES, United Kingdom

to address external questions regarding drug products. The CMC Regulatory Associate Director, Biologics is responsible... (including participating/leading HA meetings); and/or post-approval submissions. In this role, the GRS-CMC Associate Director...

Who You Are The Associate Director, Regulatory Affairs (CMC) works closely with the manufacturing department... and individual program teams to ensure CMC compliance and promote overall regulatory success. The Associate Director, Regulatory...

lives. Read more: . The CMC Regulatory Associate Director, Biologics is responsible for content development, compilation... between Global Regulatory Sciences (GRS) and Global Product and Supply (GPS). The GRS-CMC Associate Director, Biologics will assess...

to address external questions regarding drug products. The CMC Regulatory Associate Director, Biologics is responsible... (including participating/leading HA meetings); and/or post-approval submissions. In this role, the GRS-CMC Associate Director...

. Job Description The Associate Director, Analytical Regulatory Science, collaborates with product development, manufacturing and quality... and implementation of new and existing CMC regulatory guidelines and regulations to ensure approvability globally. Knowledge...

Job Description General Summary: The Associate Director, Regulatory CMC executes multi-product global regulatory... and filing of regulatory CMC submissions and manages the interactions with Health Authorities for CMC topics. This role...

be for you! As Regulatory Affairs – Chemistry, Manufacturing and Controls (CMC) Manager, you will be responsible for managing global CMC... and authors, as needed, technical (CMC) regulatory documents to support development/registration/lifecycle maintenance submission...

The Director of CMC Industry and Regulatory Intelligence is responsible for enabling chemistry manufacturing... into action and influence policy and standards for all CMC operations across Regeneron. As a Director of CMC Industry...

registration. This position comes with 4 direct reports (Dir, Sr Manager, Manager & Associate III). The Sr Director, Regulatory... Director, Regulatory Affairs CMC is also responsible for the oversight of maintaining and updating CMC sections of submissions...

management system. ORGANIZATION STRUCTURE The Senior Associate, Regulatory Operations/CMC reports into the Manager/ Director... requirements.  Knowledge/experience with CMC regulatory requirements....

OPPORTUNITY Mammoth Biosciences is hiring an Associate Director, CMC to be a key player in our product development.... Author, review, and adjudicate relevant CMC sections for US and ex-US regulatory filings as needed Work closely with cross...

on , , , and . Job Description Purpose: The Associate Director in CMC Statistics is responsible for providing statistical support across a broad range in... of strategic objectives for regulatory filings. Participate in the planning/design, conduct, analysis, and interpretation of CMC...

on , , , and . Job Description Purpose: The Associate Director in CMC Statistics is responsible for providing statistical support across a broad range in... of strategic objectives for regulatory filings. Participate in the planning/design, conduct, analysis, and interpretation of CMC...

One of AL Solutions leading biotech client's is looking for an Associate Director of Analytical Development CMC. In..., release testing, and stability studies Overseeing method validation activities and ensuring compliance with regulatory...

Associate Director-Quality Assurance (QA-CMC) Company is seeking a highly experienced, motivated, and innovative... quality leader with strong experience in early and late-stage development to join our Quality team as Associate Director...

Associate Director-Quality Assurance (QA-CMC) Company is seeking a highly experienced, motivated, and innovative... quality leader with strong experience in early and late-stage development to join our Quality team as Associate Director...

Associate Director-Quality Assurance (QA-CMC) Company is seeking a highly experienced, motivated, and innovative... quality leader with strong experience in early and late-stage development to join our Quality team as Associate Director...