- GRAIL (Albany, NY)
- …Regulatory affairs and IVD device experience required. + Direct experience with FDA regulatory submissions required. + Demonstrated knowledge of US and ... information, please visit grail.com . The role assists with regulatory strategy and the development of submissions in partnership...and activities to optimally position GRAIL products with the FDA and/or global health authorities. + Support the US… more
- Parexel (Albany, NY)
- …Adobe Acrobat, TVT, Promomats, and GLAMS. **Core Competencies:** + Knowledge of regulatory requirements relevant to drug development, global labeling, and ... markets? Parexel is seeking an experienced and highly motivated **Global Regulatory Labeling Lead** to provide strategic leadership and operational oversight for… more
- Stony Brook University (Stony Brook, NY)
- …with applicable FDA , NYSDOH, AABB, CAP requirements and other relevant regulatory agencies requirements. + Assists all areas of the hospital in the interface ... + Reviews, learns and understands all applicable CAP, AABB, FDA , NYSDOH, JCAHO etc. standards and regulations. + Prepares...(3) professional references. + Successfully complete a 4 panel drug screen * + Meet Regulatory Requirements… more
- Stony Brook University (Stony Brook, NY)
- …in the laboratory regulatory agencies such as NYSED, NYSDOH CLEP, CAP, FDA , ASHI etc. regulatory agency standards. Knowledge of quality assurance functions. ... three (3) professional references. + Successfully complete a 4 panel drug screen * + Meet Regulatory Requirements for pre employment screenings. + Provide a copy… more
- Stony Brook University (Stony Brook, NY)
- …a minimum of three (3) professional references. + Successfully complete a 4 panel drug screen * + Meet Regulatory Requirements for pre employment screenings. + ... II. * Communicate effectively with Main Laboratory, Point of Care Dept., regulatory agencies and vendor technicians * Assist in teaching respiratory therapists,… more
- Parexel (Albany, NY)
- …when applicable. + Ensure document structure, content, and style adheres to FDA /EMA or other appropriate regulatory guidelines, and comply with departmental, ... to prepare, develop, and finalize clinical documents for submission to regulatory authorities, including but not limited to: briefing documents, investigator… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- …on a broad range of healthcare regulatory matters, including regulatory labeling discussions, advertising and promotion, drug safety, market research, ... This position with the Regeneron Regulatory and Commercial Law team will provide proactive...to multiple internal stakeholders, including the commercial, medical affairs, regulatory , HEOR, corporate affairs, and compliance teams. Counsel will… more
- Sumitomo Pharma (Albany, NY)
- …clinical regulatory strategies including management of IND and NDA submissions, FDA and other global regulatory interactions, as well as international ... proposed claims and assess consistency of proposed claims with FDA -approved labeling + Provide regulatory leadership to...experience in preparing strategies for and submitting applications for drug or biologic products (INDs, NDAs, MAAs) + NDA… more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- …products and drug -device combination products. Ensure compliance with global regulations ( FDA , EMA, ICH, WHO) and anticipate regulatory changes impacting CMC ... **Job Summary** The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global … more
- Mount Sinai Health System (New York, NY)
- … Drug (IND) Applications and obtains approval from the Food and Drug Administration ( FDA ) for investigator-initiated clinical trials. Acts as primary contact ... **Job Description** A Senior Regulatory Compliance Coordinator position is currently available within...for all FDA communication, including submission of serious adverse events, amendments,… more
Recent Jobs
-
Commercial Account Executive 1
- Softchoice (TX)
-
Senior Software Developer - OCI AI Applications
- Oracle (Nashville, TN)
-
Senior Software Engineer
- Zoom (Seattle, WA)
-
IT Development Lead
- Camping World (Lincolnshire, IL)