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Keywords: Director, CMC Regulatory Affairs, Location: USA

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Director, CMC Regulatory BioPharm

? If so, this Director of Regulatory Affairs, CMC could be an exciting opportunity to explore. This role will provide... Affairs, our Chemistry, Manufacturing and Controls (CMC) organization provides regulatory leadership to CMC development teams...

Company: GlaxoSmithKline
Location: USA
Posted Date: 14 Sep 2024

Senior Director, Regulatory CMC (Chemistry, Manufacturing, and Controls)

and strategic Senior Director of Regulatory CMC to lead our Chemistry, Manufacturing, and Controls (CMC) regulatory affairs... strategy. The ideal candidate will possess extensive experience in CMC regulatory affairs, particularly in writing CMC sections...

Posted Date: 06 Sep 2024

Director Regulatory CMC

, PharmD, or PhD preferred. Minimum of 5+ years of relevant experience in CMC Regulatory Affairs for biologics, including IND...*Gene therapy experience preverred* Responsibilities: Actively represent Regulatory CMC and provide regulatory...

Company: Actalent
Location: Boston, MA
Posted Date: 08 Nov 2024

Director, Regulatory Affairs, Oncology Early Development

to discover and develop novel cancer treatments. We are currently seeking a Regulatory Affairs Director to join our growing... degree preferred. 8 – 12 years of experience in Regulatory Affairs (strong preference for experience in oncology) in the...

Company: AbbVie
Location: San Francisco, CA
Posted Date: 13 Nov 2024

Director, Regulatory Affairs, Oncology Early Development

to discover and develop novel cancer treatments. We are currently seeking a Regulatory Affairs Director to join our growing... degree preferred. 8 - 12 years of experience in Regulatory Affairs (strong preference for experience in oncology) in the...

Company: AbbVie
Location: San Francisco, CA
Posted Date: 13 Nov 2024

Director - Regulatory Affairs

Position: Director - Regulatory Affairs Role Summary: Lead regulatory strategy and submissions. Collaborate... approvals. - Strong regulatory knowledge of drug development including CMC, preclinical, clinical, and post-marketing phases...

Company: KOB Solutions
Location: Branchburg, NJ
Posted Date: 13 Nov 2024

Director - Regulatory Affairs

Position: Director - Regulatory Affairs Role Summary: Lead regulatory strategy and submissions. Collaborate... approvals. - Strong regulatory knowledge of drug development including CMC, preclinical, clinical, and post-marketing phases...

Posted Date: 13 Nov 2024

Director - Regulatory Affairs

Position: Director - Regulatory Affairs Role Summary: Lead regulatory strategy and submissions. Collaborate... approvals. - Strong regulatory knowledge of drug development including CMC, preclinical, clinical, and post-marketing phases...

Posted Date: 13 Nov 2024

Director - Regulatory Affairs

Position: Director - Regulatory Affairs Role Summary: Lead regulatory strategy and submissions. Collaborate... approvals. - Strong regulatory knowledge of drug development including CMC, preclinical, clinical, and post-marketing phases...

Location: Branchburg, NJ
Posted Date: 13 Nov 2024

Director - Regulatory Affairs

Position: Director - Regulatory Affairs Role Summary: Lead regulatory strategy and submissions. Collaborate... approvals. - Strong regulatory knowledge of drug development including CMC, preclinical, clinical, and post-marketing phases...

Location: Branchburg, NJ
Posted Date: 13 Nov 2024

Director - Regulatory Affairs

Position: Director - Regulatory Affairs Role Summary: Lead regulatory strategy and submissions. Collaborate... approvals. - Strong regulatory knowledge of drug development including CMC, preclinical, clinical, and post-marketing phases...

Location: Branchburg, NJ
Posted Date: 12 Nov 2024

Director - Regulatory Affairs

Position: Director - Regulatory Affairs Role Summary: Lead regulatory strategy and submissions. Collaborate... approvals. - Strong regulatory knowledge of drug development including CMC, preclinical, clinical, and post-marketing phases...

Posted Date: 12 Nov 2024

Regulatory Affairs Director - Global Regulatory Lead

. Regulatory Affairs Director - Global Regulatory Lead What you will do Let’s do this. Let’s change the world. Amgen is seeking... a Regulatory Affairs Director supporting products in Obesity Therapeutic Area. Global Regulatory Affairs (GRA) provides global...

Company: Amgen
Location: USA
Posted Date: 08 Nov 2024

Regulatory Affairs Director - Global Regulatory Leader (General Medicine/Cardiovascular)

. Regulatory Affairs Director - Global Regulatory Leader (General Medicine/Cardiovascular) What you will do Let’s do this. Let...’s change the world. Amgen is seeking a Regulatory Affairs Director supporting products in the General Medicine – Cardiovascular...

Company: Amgen
Location: USA
Posted Date: 08 Nov 2024

Regulatory Affairs Director - Oncology

and effectively as possible. The Regulatory Affairs Director (RAD) provides strategic and operational regulatory leadership to the... Regulatory Strategy Team (GRST) of key contributing members from the regions, emerging markets, RA CMC, Labelling and members...

Company: AstraZeneca
Location: New York City, NY
Posted Date: 07 Nov 2024

Regulatory Affairs Director - Oncology

of. Regulatory Affairs Director - Global Regulatory Leader - Oncology Live What you will do Let’s do this. Let’s change the... world. Amgen is seeking a Regulatory Affairs Director supporting products in the Oncology Therapeutic Area. Global...

Company: Amgen
Location: USA
Posted Date: 06 Nov 2024

Sr. Director, Global Regulatory Affairs

JOB TITLE: Sr. Director, Global Regulatory Affairs REPORTS: Vice President, Regulatory Affairs DEPARTMENT: Regulatory... Affairs DATE PREPARED: October 17, 2024 JOB SUMMARY: AVEO Oncology is seeking an experienced Senior Director, Regulatory...

Company: AVEO Oncology
Location: Boston, MA
Posted Date: 26 Oct 2024

Global Oncology Pediatric Regulatory Strategist (Senior Regulatory Affairs Director)

The Senior Regulatory Affairs Director (SRAD) responsible for oncology paediatric regulatory strategy (OPRS) serves... against aspirations and update ORSSE Leadership on project risks/mitigation activities. Represent Regulatory Affairs on Global Product...

Company: AstraZeneca
Location: Gaithersburg, MD
Posted Date: 23 Oct 2024

Director, Regulatory Affairs - Clinical

-world evidence, and creating hope for all facing illness. The Director, Regulatory Affairs provides strategic global... coordinating regulatory workflow, reviewing technical documents (nonclinical, clinical, and CMC), developing, and tracking...

Posted Date: 18 Oct 2024

DIRECTOR REGULATORY AFFAIRS

SUMMARY OF POSITION The Director, Regulatory Affairs integrates and applies knowledge of US regulatory guidelines... complex project related matters to FDA.  Advanced understanding of pharmaceutical development and CMC regulatory affairs...

Company: TK-CHAIN LLC
Location: Princeton, NJ
Posted Date: 07 Oct 2024
Salary: $90000 - 180000 per year