| Job alert | Jobs 31 - 40 of 821 |
Senior Manager, US Medical Review
Alexion Pharmaceuticals, Inc.
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Boston, MA, 02298
... * Understanding of drug development, US (FDA)and global (e.g. EMEA) regulations and reporting requirement for reporting pharmacovigilance events and product quality complaints * Strong written and verbal communication skills * Proficiency in ... - Jun 08
Director Regulatory Strategy
Meet
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Cambridge, MA, 02140
... This position offers the chance to influence and drive regulatory strategies that align with our cutting-edge oncology assets, fostering collaboration with the FDA to expedite the development and approval of new therapies. Key Responsibilities: ... - May 26
Quality Control Manager
North Coast Seafoods
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Boston, MA
... root cause analysis and corrective action Plan, prepare and participate in all audits including: organic, kosher, customer, FDA, internal and 3rd party Sustain and improve ratings on annual certifications Performs other related duties as assigned ... - Jun 03
Senior/ Principal Medical Writer
CRISPR Therapeutics
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South Boston, MA, 02127
... problem-solving capabilities Aptitude for data compilation, analysis, and presentation Knowledge of Good Clinical Practices, FDA regulations, ICH guidelines, and the drug development process Ability to manage multiple projects in a fast-paced and ... - Jun 17
Global Regulatory Strategy Director
Integrated Resources
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Boston, MA, 02298
... • Representing Client as point contact FDA and leading Client delegation for regulatory authority meetings. • Leading US submissions to regulatory authorities in support of proposed and ongoing development programs, e.g., new clinical trial ... - Jun 17
Associate Director of Manufacturing
DSJ Global
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Boston, MA, 02298
... Regulatory Compliance: Ensure all manufacturing activities comply with FDA, EMA, and other relevant regulatory agencies. Prepare and review documentation required for regulatory submissions and audits. Stay updated on industry regulations and ... - Jun 18
Director of Quality Assurance
Sci-Rec
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Boston, MA, 02298
... Demonstrate knowledge of cGMP requirements and practices including extensive knowledge of the EMA/EP and FDA/USP Guidance Documents for biologics; Good understanding of pharmaceutical biotech operations and/ or CDMO business; University degree in ... - Jun 18
Quality Manager for High Complexity CLIA Lab
Nanobiosym
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Cambridge, MA, 02142
... The position requires extensive cross-functional interaction throughout the organization, strong liaison activities with senior management, as well as with external notified bodies and third parties including CLIA, FDA and other global regulatory ... - Jun 12
Senior Electrical Engineer (Medical Device)
Intellectt Inc
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Boston, MA, 02298
... RESPONSIBILITIES: Highlights: Med device, FDA, generating IQ/OQ, PQ. Company similar to ours that realizes Main designer for the next set of circuit board, cross functionally with software and design Bright, good decision making capabilities ... - Jun 18
Associate Director, US Advertising and Promotion, Global Regulatory
Sanofi EU
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Cambridge, MA
... As the RC Regulatory Affairs representative, work with brands on competitively positioning assigned products appropriately while maintaining compliance with applicable FDA regulations, company policies, and applicable Industry Guidelines for the ... - Jun 17