Regulatory Affairs Jobs in Cambridge
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Search Results - Regulatory Affairs Jobs in Cambridge
Executive Director, Global Regulatory Affairs CMC Devices and Drug-Device Combination Product (Hirin
Takeda Pharmaceutical-Cambridge
Affairs CMC Devices and Drug-Device Combination Product, you will provide strategic leadership and development to global regulatory subject matter experts to ensure innovative and robust regulatory strategies for medical devices and drug-device combination...
tdrct.com -
Apnimed-Cambridge
are continuing to grow and build the foundational operations that enable our employees, and our mission, to thrive.
Position Summary
We are seeking an experienced and strategic Senior Director of Regulatory Affairs Advertising/Promotion to lead FDA-focused...
appcast.io -
Takeda Pharmaceutical-Cambridge
Affairs CMC Devices and Drug-Device Combination Product, you will provide strategic leadership and development to global regulatory subject matter experts to ensure innovative and robust regulatory strategies for medical devices and drug-device combination...
tdrct.com -
Randstad USA-Cambridge
Regulatory Affairs and MS&T to support the complaint management program for company. This individual will support quality systems and governance, initiate complaints, initiate, and manage compliant investigations and drive continuous GMP improvement...
appcast.io -
Takeda Pharmaceutical-Cambridge
therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.
The Director Global Regulatory Affairs...
tdrct.com -
Beacon Hill-Cambridge
the trial is preferred
Experience with global studies, using an outsourced CRO model
Experience in clinical drug development
Experience with regulatory affairs, including IND/CTA submissions
Position Overview: The CTA position will assist with daily...
appcast.io -
Takeda Pharmaceutical-Cambridge
independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including...
tdrct.com -
Beacon Hill-Cambridge
the trial is preferred
Experience with global studies, using an outsourced CRO model
Experience in clinical drug development
Experience with regulatory affairs, including IND/CTA submissions
Position Overview: The CTA position will assist with daily...
lwqct.com -
Takeda Pharmaceutical-Cambridge
Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team's delivery of critical functions as follows:
• With minimal supervision, develops and leads the execution of regulatory CMC investigational...
tdrct.com -
Takeda Pharmaceutical-Cambridge
assessments, safety evaluations, and clinical components of regulatory submissions are of the highest quality and aligned with global regulatory expectations.
• Provide strategic leadership oversight for global medical affairs strategies, including scientific...
mindmatch.ai -
Cambridge
of‑concept study design
• Collaborate closely with Preclinical, Regulatory Affairs, Biostatistics, Clinical Operations, Medical Affairs, Commercial, and Quality teams to ensure integrated development strategies
• Lead and supervise major clinical deliverables...
pharmiweb.jobs -
Pfizer-Cambridge
functions such as regulatory affairs, pharmacovigilance, biostatistics, and medical affairs to ensure that the clinical development program meets the scientific, ethical, and regulatory standards. The medical director also provides medical expertise...
dejobs.org -
Editas Medicine-Cambridge
quality, and regulatory readiness, ensuring successful EDIT-401 IND submission and Clinical Trial execution.
The role serves as a critical bridge between DSTS/RTO, Clinical Development, and CMC working closely with Clinical Operations, Regulatory Affairs...
workable.com -
Cambridge
continuous improvement, innovation and appropriate risk taking.
• Demonstrates resilience and perseverance.
Degree / Experience Requirements
• Solid scientific background, Ph.D., M.D., PharmD, MS, or BS
• Significant experience in regulatory affairs (e.g...
pharmiweb.jobs -
Takeda Pharmaceutical-Cambridge
Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team's delivery of critical functions as follows:
• Independently develops the regulatory CMC strategy and leads the execution of regulatory CMC...
tdrct.com -
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