Showing 1-20 of 489
Showing 1-20 of 489
Director Regulatory Cmc jobs

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SanofiWestborough, MA

Lead ot h er CMC projects as needed. Ja p an A ccre d i tat i on) o Post-Market i ng Comm i t m ents (PMCs) and Other Regulatory Co m mitments(ex....

Jubilant Cadista Pharma IncYardley, PA

Prepare / review CMC submission documents from regulatory perspective to meet scientific and technical requirements for acceptability and approvability by FDA....

AbbVieSouth San Francisco, CA

Coordinates strategic and operational efforts with Clinical Development, Regulatory, CMC, and Commercial to result in global regulatory approvals....

Meet RecruitmentSan Diego, CA

Works with CMC Regulatory, Regulatory Project Management and submission management on development and regulatory filing strategies....

Boehringer IngelheimFremont, CA

Associate Director, CMC Project Leader. Initiates and monitors the generation of regulatory documents by the CMC DRA representative and relevant team members....

Sun Pharmaceutical Industries, Inc.Cranbury, NJ

Ensure that R&D remains always one step ahead of new regulatory trends. For the Global R&D Quality Assurance Department, this position leads and directs one of...

RBParsippany, NJ

Identify, communicate and escalate potential CMC Regulatory issues to Regulatory Management, as needed; Deliver all CMC Regulatory milestones for assigned...

SanofiWestborough, MA

CMC dossiers include, but not limited to, clinical study applications (IND/IMPD/CTA), market authorization applications (BLA/NDA/MAA) and regulatory documents...

NantKwestCulver City, CA

Director, the Regulatory Affairs Manager implements CMC regulatory strategies for assigned projects, defines CMC requirements and authors CMC sections of...

Meet RecruitmentEmeryville, CA

The Senior Director of Regulatory Affairs will provide leadership on global regulatory activities. Responsibility includes nonclinical, clinical and CMC...

SanofiFramingham, MA

Providing strong scientific mentorship to direct reports who have both managerial and CMC analytical project leadership roles that support process development,...

Advanced ClinicalPrinceton, NJ

Determines regulatory requirements for clinical and pre-clinical submissions to. Are you a Senior Manager Regulatory Strategy professional with five years of...

Meet RecruitmentSan Diego, CA

Minimum of 5-7 years CMC regulatory affairs experience. Oversee preparation, review and submission of CMC regulatory documents to regulatory agencies and ensure...

Meet RecruitmentSan Carlos, CA

Manage/lead regulatory activities associated with Alkahest’s drug development programs. Function as the primary liaison with FDA and other regulatory agencies....

Sage TherapeuticsCambridge, MA

Experience in writing regulatory documents and submissions. Authors and reviews drug substance related sections of regulatory filings....

Sage TherapeuticsCambridge, MA

Ensures effective communication, collaboration and documentation of all CMC aspects of the program, including preparation of reports and regulatory filings....

Sage TherapeuticsCambridge, MA

Actively contributes to CMC teams, and ensures alignment of manufacturing and technology transfer activities with CMC and program development plans....

Meet RecruitmentRedwood City, CA

Responsibility includes nonclinical, clinical and CMC regulatory filings and providing strategic as well as operational leadership on the project teams in these...

Corcept TherapeuticsMenlo Park, CA

Draft CMC sections of regulatory submissions. Detailed knowledge of ICH Q7 guidance, FDA and EU regulatory guidance for CMC....


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