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…
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…
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: Lead the preparation, review, and submission of CMC sections of regulatory filings (e.g., INDs, NDAs, BLAs, MAAs, variations, renewals) to global health authori…
Viatris Specialty LLC At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of ev…
SUMMARY OF POSITION Independently authors, compiles, reviews, schedules, and submits high-quality regulatory submissions in adherence with technical document standards that are fu…
Position The Director, Regulatory CMC will be responsible for overseeing the development and execution of regulatory strategies for Chemistry, Manufacturing, and Controls (CMC) a…
SUMMARY OF POSITION The Sr. Manager, Regulatory Affairs integrates and applies knowledge of US regulatory guidelines and federal regulations governing pharmaceutical drug developm…
Innova Solutions is immediately hiring a Global Regulatory CMC Manager Job Title: Global Regulatory CMC Manager Position type: Full-time Contract Duration: 09 Months Location:…
Responsibilities: Prepare and review CMC submission documents, registration dossiers, health authority briefing packages and responses to health authorities through collaboration…
Innova Solutions is immediately hiring for an Global Regulatory CMC Manager Tittle: Global Regulatory CMC Manager Duration: 9 months Contract Location: Lawrenceville ,NJ (onsite…
Responsibilities: Participate in the development of the CMC regulatory strategy for small molecules, biologics and cell therapy submissions. These submissions include health auth…
Responsibilities: Participate in the development of the CMC regulatory strategy for small molecules. These submissions include health authority briefing packages, IND/CTA, NDA, a…
Job Description General Summary: The Director, Regulatory CMC (Chemistry Manufacturing Controls) leads a cell therapy combination product program from development through comme…
Here at Ascendis we pride ourselves in exceptional science, visionary leadership, skilled and passionate colleagues. We are a dynamic, fast-growing biopharma company with offices…
Summary This position reports to the Functional Area Head, Global Regulatory Affairs. The incumbent responsible for supporting the development and implementation of regulatory st…
Experic is an industry-leading contract development and manufacturing organization (CDMO) and clinical trial supply services company. Our vision is to deliver innovative and scalab…