Regulatory Affairs Jobs in Lexington (MA)
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uniQureLexington (MA)appcast.io
the impossible possible, where your expertise becomes a catalyst for life-changing treatments.
The Vice President, Advertising and Promotion Regulatory Affairs will report to the Senior Vice President Global Regulatory Affairs. This position will be responsible...
Wave Life SciencesLexington (MA)
Overview
In this role you collaborate with QA and Regulatory Affairs to optimize and validate GxP computerized systems. You will translate regulatory needs into compliant system requirements and guide lifecycle activities from intake to validation...
uniQureLexington (MA)appcast.io
uniQure is seeking a Vice President, Advertising and Promotion Regulatory Affairs to lead US promotional compliance and strategy for prescription products including gene therapies. You will serve as the expert on FDA regulations and liaise...
Pulpdent CorporationWatertown (MA), 7 mi from Lexington (MA)
To learn more about Pulpdent, including its breakthrough advances in bioactive dental materials and commitment to ethical business practices, visit pulpdent.com.
Job Summary
The Head of Regulatory Affairs will lead and evolve Pulpdent’s global regulatory...
Agenus IncLexington (MA)appcast.io
submissions, remaining sufficiently hands-on to personally author or shape critical content when needed.
• Partner with Regulatory Affairs to define and drive global clinical regulatory strategy and represent the clinical development perspective...
Noema PharmaWatertown (MA), 7 mi from Lexington (MA)join.com
using our novel therapies.
Tasks
The Director of Regulatory Affairs provides strategic and operational leadership to the development and commercialization of products for one or more of the Company’s clinical programs. Reporting to the SVP, Regulatory...
Regulatory JobsLexington (MA)appcast.io
Collaborate with CMC, Regulatory Affairs, Clinical, Pharmacovigilance, and Supply Chain to ensure integrated quality oversight.
• Influence and align stakeholders at all levels to drive compliance and business objectives.
Standout Skills for Impact...
InsmedBoston, 11 mi from Lexington (MA)
correspondence and submissions accurately; ensure lifecycle management activities
Key requirements
• Bachelor’s degree in a scientific discipline
• 10+ years in Global CMC Regulatory Affairs or relevant pharma/biotech development experience
• 5+ years of gene...
USA - 3345 Takeda Manufacturing U.S.A., IncLexington (MA)appcast.io
fostering technical excellence, talent development, accountability, inclusion and cross-functional collaboration.
• Partner with senior leaders across R&D, MSAT, Quality, Regulatory Affairs, Procurement, Commercial, manufacturing sites and external suppliers...
IlluminaBoston, 11 mi from Lexington (MA)
Responsibilities
• Represent the regulatory affairs function on cross-functional projects
• Create regulatory strategies for domestic and international markets
• Develop and execute regulatory plans for complex products and maintain approvals
• Prepare information...
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