Job Summary: Medical Device Quality Engineer responsible for supporting the launch of a new medical device product into production at an onsite manufacturing facility in Devens, MA. The role focuses on process validation, risk managemen...
Responsibilities: Lead data management activities as a program-level lead data manager in support of Alnylam clinical studies. Lead database build activities including leading cross-functional review of eCRF content, review of edit check...
Responsibilities: This role is responsible for Regulatory Affairs support of submissions and ongoing regulatory compliance for product development process and sustaining engineering projects, ensuring compliance with FDA and EU regulation...
Responsibilities: Participate in the development of the CMC regulatory strategy for small molecules. These submissions include health authority briefing packages, IND/CTA, NDA, and MAA regulatory filings. Prepare and review CMC submissio...
Roles & Responsibilities: Provides analytical support in Project Management under minimal supervision. Supports the Project and Program Review meetings including information gathering across all projects, meeting operations, and manage m...
Job Description: This position is responsible for efficient and effective performance of sampling raw materials and testing (except for the raw materials chemicals) in conformance with regulations and standards. Responsibilities: Mainta...
Responsibilities: Lead the preparation, review, and submission of CMC sections of regulatory filings (e.g., INDs, NDAs, BLAs, MAAs, variations, renewals) to global health authorities, ensuring accuracy, completeness, and compliance with a...
Job description: The Biologics CMC Developability (BCD) group sits at the interface of discovery and development. The core role of BCD is to deliver meaningful and actionable data to support the selection of candidate molecules to progress...
Responsibilities: The Regulatory Manager (RM) provides regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures, ...
Job Description: The Quantitative, Translational ADME Sciences (QTAS) department at client is seeking a highly motivated and energetic bioanalytical scientist to join the biologics bioanalysis, characterization and proteomics (BBCP) group....