CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions…
Job Description About This Role This role is responsible for Regulatory CMC expertise into the development and implementation of the global regulatory strategy, operations and p…
Position The Director, Regulatory CMC will be responsible for overseeing the development and execution of regulatory strategies for Chemistry, Manufacturing, and Controls (CMC) a…
Job Description: Great Science. Deep Compassion. Real Impact. Alkermes is offering exciting opportunities through our commitment to work together to help improve the lives of p…
Responsibilities: Responsible to communicate new regulatory guidelines. Lead the strategic efforts in the interpretation of relevant and new quality guidelines to ensure that the…
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed…
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed…
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees ar…
Does leading and delivering Chemistry and Manufacturing Controls regulatory strategy interest you? If so, this role may be for you! As Regulatory Affairs – Chemistry, Manufacturi…
The candidate will support the development and execution of regulatory strategies for biologic products and combination products for the portfolio assigned and perform the duties o…
Responsibilities: Prepare and review CMC submission documents, registration dossiers, health authority briefing packages and responses to health authorities through collaboration…
Who we are Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our…
Responsibilities: Participate in the development of the CMC regulatory strategy for small molecules, biologics and cell therapy submissions. These submissions include health auth…
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees ar…
SUMMARY OF POSITION Independently authors, compiles, reviews, schedules, and submits high-quality regulatory submissions in adherence with technical document standards that are fu…
Job Description General Summary: The Director, Regulatory CMC (Chemistry Manufacturing Controls) leads a cell therapy combination product program from development through comme…
Job Description General Summary: The Director, Regulatory CMC (Chemistry Manufacturing Controls) is responsible for the development and implementation of post-approval global reg…
Responsibilities: Lead the preparation, review, and submission of CMC sections of regulatory filings (e.g., INDs, NDAs, BLAs, MAAs, variations, renewals) to global health authori…
Responsibilities: Participate in the development of the CMC regulatory strategy for small molecules. These submissions include health authority briefing packages, IND/CTA, NDA, a…
The Manager, CMC Regulatory Sciences for Clinical Submissions leads a team that manages the CMC regulatory submission work across multiple clinical programs and/or submissions. A…