- Cambrex High Point (Waltham, MA)
- …NMR, TGA, DSC, particle size analyzer etc. to characterize and quantitate pharmaceutical synthetic molecules. Knowledge of regulatory guidelines and experience ... 1+ years of experience in analytical chemistry within the pharmaceutical industry. The candidate should have a broad experience...Author and review analytical protocols, reports, and SOPs in compliance with GMP and regulatory expectations. +… more
- United Therapeutics (Houston, TX)
- …. The Director, DPF Site Operations role is pivotal in maintaining regulatory compliance , upholding the highest quality standards, and driving operational ... We Are** We are the first publicly-traded biotech or pharmaceutical company to take the form of a public...Food and Drug Administration (FDA) and, as appropriate, ex/US regulatory agencies + Strong knowledge of cGMP compliance… more
- Providence (Portland, OR)
- …areas: **_Leadership oversight_** **_:_** + Accountability for financial sustainability, regulatory compliance , operational efficiency, and clinical and quality ... through complex political situations effectively + Assists all pharmacy leaders regarding compliance with all professional, regulatory , and legal standards in… more
- WuXi AppTec (Middletown, DE)
- …technologies, equipment, and relevant software. Knowledge of cGMP guidelines and regulatory compliance is essential. + Analytical & Problem-Solving: Ability ... with the preparation and maintenance of User Requirements Specifications. + Ensuring compliance with regulatory requirements (FDA, EMA, cGMP), quality standards,… more
- Lilly (Philadelphia, PA)
- …transfer, cGMP manufacturing, analytical development, release, quality control, and regulatory expectations for pharmaceutical products. + Direct experience ... Development, Analytical Sciences, Manufacturing, Quality, Supply Chain, R&D, Finance, and Regulatory to ensure delivery of CMC milestones for priority assets… more
- Bristol Myers Squibb (Trenton, NJ)
- …a risk-based approach. **Key Responsibilities** * Monitor and assess global regulatory inspection outcomes, enforcement actions, quality and compliance metrics, ... and Compliance teams to prepare for and manage global regulatory inspections, including supporting the creation of comprehensive written responses to inspection… more
- Sutter Health (Berkeley, CA)
- …Cancer Center **Position Overview:** Provides timely and accurate pharmaceutical care. Prepares, compounds, packages, labels, and dispenses medication, ... adequate stock levels, checking accuracy of pricing, and completing required regulatory documentation. Adheres to all standards, procedures, cleaning protocols, and… more
- Cognizant (Boston, MA)
- …advanced degree preferred. Certifications: (Optional) ISTQB, PMP, or relevant regulatory compliance certifications. **_Roles & Responsibilities_** Develop and ... transformation and paperless execution. . Collaborate with project stakeholders, including regulatory and compliance teams, to establish Validation and testing… more
- Merck (Rahway, NJ)
- …utilization and the efficient management of data across the organization, including compliance with regulatory standards, and the optimization of laboratory ... industry trends and emerging technologies to recommend innovative solutions in compliance and regulatory ISO-13485 standards. **Stakeholder Engagement** +… more
- Takeda Pharmaceuticals (Lexington, MA)
- …IIR within assigned TA in accordance with all applicable internal legal and compliance policies as well as external US-specific regulatory guidelines. + Partners ... development (eg, thru Patent Exclusivity expiration). + Thorough understanding of legal, compliance , and regulatory guidelines related to the conduct of a… more