Regulatory Affairs Jobs in Waltham (MA)
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Disability Solutions-Waltham (MA)-
benefits and life at GSK on our webpage Life at GSK | GSK
Find out more about GSK and R&D: Our approach to R&D
Global Regulatory Affairs Manager, Oncology
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion...
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Deciphera Pharmaceuticals-Waltham (MA)-
Overview
In this role you will lead global clinical supply planning and execution to ensure uninterrupted investigational product availability. You will partner across Clinical Operations, CMC, QA, Regulatory Affairs, and external vendors...
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Madrigal-Waltham (MA)-appcast.io-
we are strengthening our workforce strategy to ensure we have the right talent, at the right time, in the right way.
The Senior Director of Regulatory Affairs CMC provides highly strategic, tactical and operational regulatory CMC leadership...
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GSK-Waltham (MA)-
affairs and commercial
• Define the oncology vaccine strategy within GSK's R&D portfolio and translate it into actionable asset plans
• Deliver evidence packages (immunogenicity, biomarkers, efficacy) to support regulatory approval and market access...
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Kailera Therapeutics, Inc.-Waltham (MA)-appcast.io-
talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.
What You’ll Do:
Vice President of CMC Regulatory will lead all aspects of CMC Regulatory. Reporting into the Senior Vice President of Regulatory, you...
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GSK-Waltham (MA)-
Regulatory affairs and submissions
• Evidence generation and pharmacovigilance...
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Madrigal-Waltham (MA)-appcast.io-
Madrigal is a biopharmaceutical company focused on therapies for MASH. The Senior Director of Regulatory Affairs CMC provides strategic CMC leadership for clinical trials, registrations, and post-approval activities, leading cross-functional teams...
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Kailera Therapeutics, Inc.-Waltham (MA)-appcast.io-
Kailera Therapeutics, Inc. is seeking a Vice President of CMC Regulatory to lead all aspects of CMC regulatory affairs. The role reports to the Senior Vice President of Regulatory and supports Phase 3 readiness, regulatory strategy, and global...
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Disability Solutions-Waltham (MA)-
currently has opportunities in its Global Regulatory Affairs (GRA)- Labelling department, within Research and Development, and this Labelling role may be an ideal opportunity for you to explore.
At GSK, we're constantly developing new products and improving...
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Madrigal Pharmaceuticals, Inc.-Waltham (MA)-appcast.io-
evaluation for assigned compounds in development and in the postmarketing setting. The role requires strong collaboration within Global Clinical Safety and Pharmacovigilance and across Clinical Development, Regulatory Affairs, Biostats, and Clinical...
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Disability Solutions-Waltham (MA)-
strategy for hematalogic cancer programs.
• Cross-functional Leadership: Lead multidisciplinary teams, including clinical scientists, medical directors, regulatory affairs, and biostatistics professionals.
• Portfolio Oversight: Provide oversight...
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Disability Solutions-Waltham (MA)-
evidence, or novel trial design
Skills
Clinical Data Interpretation, Clinical Trial Designs, Clinical Trials Monitoring, Digital Fluency, Drug Development, Drug Regulatory Affairs, Evidence Based Decision Making, Executive Presence, Hematology and Oncology...
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Disability Solutions-Waltham (MA)-
enabling key decision points and go/no-go criteria for the CDP.
• Establish and maintain relationships with program counterparts in biology, translational sciences, commercial, regulatory, clinical operations, market access, medical affairs and statistics...
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Disability Solutions-Waltham (MA)-
and experience
We are looking for candidates with:
• A bachelor's degree or equivalent relevant professional experience in biological science, healthcare science or a related discipline.
• Significant regulatory-affairs experience across pharmaceutical...
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Women In Bio-Waltham (MA)-appcast.io-
Interpretation, Clinical Data Review, Clinical Development, Clinical Trial Designs, Clinical Trials Monitoring, Digital Fluency, Drug Regulatory Affairs, Executive Presence, Hematology and Oncology, Learning Agility, Matrix Leadership, Real World Evidence (RWE...
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