| Job alert | Jobs 1 - 10 of 449 |
Sr. Director, PV Medical Surveillance
Taiho Oncology
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Princeton, NJ
... The candidate should have extensive knowledge of ICH/FDA/EMA guidelines for GCP and Clinical and post-marketing Safety Reporting. Highly developed skills in verbal and written communication, planning, organization, with extensive knowledge of the ... - Jun 17
Sr. Study Manager, Clinical Operations
Taiho Oncology
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Princeton, NJ
$158,100 - $186,000 annual
... Takes initiative and utilizes good judgment Knowledge of, and competence in, application of FDA/GCP/ICH guidelines The pay range for this position at commencement of employment is expected to be between $158,100 - $186,000 annually; however, base ... - Jun 17
Quality Consultant SME Pharma Medical Devices
Excellis Health
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New Hope, PA, 18938
... Understanding and interpreting the FDA regulations for both Pharmaceutical and Medical Device products including those for developing, filing/approving, manufacturing, labeling, packaging, testing, storing and distributing the products Understanding ... - May 28
ASSOCIATE II REGULATORY LABELING
TK-CHAIN LLC
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West Windsor Township, NJ, 08540
Job Description SUMMARY OF POSITION The Associate, Regulatory Labeling prepares, reviews and submits to his/her manager high-quality regulatory labeling submissions intended for the FDA within company timelines and in accordance with regulatory ... - Jun 08
Drug Safety Associate
Zydus Pharmaceuticals USA
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Pennington, NJ, 08534
... Evaluate cases for seriousness and expectedness criteria, distribute AE reports to plant QA/GPV/Partner companies in accordance with Safety Data Exchange Agreements (SDEAs), & take appropriate decisions by applying knowledge of FDA/ICH GCP/GVP ... - Jun 07
Quality Control Lab Technicians - Food Plant
Johanna Foods, Inc.
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Flemington, NJ
... Performs tests to keep lab in compliance with FDA lab requirement. Testing includes but is not limited to, pH, Total Solids, Brix, Butterfat. Testing- Gerber Method, ATP, and Chemical Titrations. Conducts calibrations of instruments and devices ... - Jun 16
Regulatory Associate
KVK Tech
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Newtown, PA
... while maintaining compliance with cGMP requirements, FDA, OSHA, EPA, and DEA. 2. Key Duties & Responsibilities: Interacts effectively with cross functional teams to coordinate/facilitate procurement of documentation required for regulatory ... - Jun 08
MANAGER REGULATORY AFFAIRS
TK-CHAIN LLC
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West Windsor Township, NJ, 08540
... Associates in regulatory activities associated with planning, authoring, compiling and submitting highest-quality regulatory submissions to the FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws. ... - Jun 08
Regulatory Group Leader
KVK Tech
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Newtown, PA
... while maintaining compliance with cGMP requirements, FDA, OSHA, EPA, and DEA. 2. Key Duties & Responsibilities: Trains Regulatory Associates Collaborates with R&D, QC and Production Managers Handles all aspects of regulatory submissions (i.e. ANDA ... - Jun 02
DIRECTOR REGULATORY AFFAIRS
TK-CHAIN LLC
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West Windsor Township, NJ, 08540
... Continually monitors newly published FDA guidelines in the context of new and ongoing development programs and will provide training on applicable requirements for regulatory and scientific staff as required. Collaborates with functional groups to ... - Jun 08