- Novo Nordisk Inc. (Plainsboro, NJ)
- …within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education ... regulatory labeling-related activities. Updates internal processes to ensure compliance with health authority requirements and expectation Physical Requirements… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product ... labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an...cross functional teams through all labeling discussions with the FDA /CHMP while ensuring management alignment. Strategizes and plans for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education ... financial milestones and related payment schedules) Advanced knowledge of Regulatory and Compliance requirements related to Pharmaceutical… more
- Aequor (Chattanooga, TN)
- …Good Manufacturing Practices (GMP) Compliance , and Food and Drug Administration ( FDA ) regulatory standards. Maintain compliance with all state and ... Peer Relationships, Directing Others, and Comfort Around Higher Management o Experience in Food or Pharma manufacturing following FDA regulations is preferred. more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) ... operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Oversees Local/Global ... tracks regulatory trends, legislative changes, and guidelines issued by global regulatory agencies ( FDA , EMA, MHRA, etc.) related to CSPV. Participates in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …existing CMR employee on-boarding, cultural engagement, technical/role-specific training and GxP/ Regulatory compliance across CMR functions. Position will serve ... within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education… more
- Merck & Co. (Rockville, MD)
- Job DescriptionThe Science and Regulatory Policy (SRP) team advocates for policy priorities that support the pipeline and portfolio for our Research & Development ... business goals.The SRP team comprises of four contributing teams:Global Regulatory Policy (GRP)Data & Advanced Digital Technology Policy (DADTP)Evidence Policy,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary This position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as ... operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned… more
- Merck & Co. (Durham, NC)
- …Quality Control will be responsible for activities that support cGMP and regulatory compliance during method qualification/validation and routine product testing ... for the company; uses this knowledge in own workUnderstands and applies regulatory / compliance requirements relative to their roleInfluence, motivate, and… more
- Merck & Co. (Durham, NC)
- …Manager will be responsible for activities that support cGMP and regulatory compliance during facility design, construction, start-up method transfer/validation ... for the company; uses this knowledge in own workUnderstands and applies regulatory / compliance requirements relative to their roleInfluence, motivate, and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education ... & conduct of clinical trials In-depth knowledge & direct experience/interactions with the FDA (or equivalent regulatory authority) in relation to the design,… more
- Merck & Co. (Rahway, NJ)
- …sites, manufacturing investigations, process validation, and authoring of regulatory submissions. -Under the general scientific and administrative direction ... next generation process development and characterization, process validation, and regulatory submission authoring. In this role, the successful candidate will… more
- Merck & Co. (Rahway, NJ)
- …products and processes are developed in accordance with applicable regulatory , quality, company, and customer requirements.-This position will lead cross-functional ... full integration of the device development activities with the clinical, regulatory , formulation, commercial and other key Ofunctions.Lead the Device Development… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …the various subunits of the Quality System and ensuring accountability. Achieving compliance with cGMP and other relevant regulatory requirements and fostering ... Operating Procedures, Work Instructions, Deviations, and other quality documents for cGMP compliance and consistency with FDA regulations. Aiding members of the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …requirements.Strive to reduce non-conformances in supported areas by dedicatedly driving compliance .Ensure readiness of records for regulatory inspections and ... responsible for quality and maintaining the highest standards in compliance within company policies, procedures, and all applicable regulations.Key Responsibilities… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Programs, Patient Safety, Quality, NNI IT and Telephony, Medical Information, Compliance , Regulatory , Legal and Privacy. External relationships include Patient ... complaints and other safety information related to Novo Nordisk products and in compliance with Novo Nordisk and FDA requirements Understands PSP operations,… more
- Merck & Co. (Rahway, NJ)
- …non-sterile and sterile products.- It also includes strategic partnering with CMC and Regulatory in aspects of control strategy and filings, Quality and our partners ... oral, and specialty dosage formulations.- The director should be well engaged with regulatory and industry trends to guide future activities for Analytical R&D and… more
- Merck & Co. (Rahway, NJ)
- …phase drug product manufacturing processes to GMP production facilities.Experience authoring regulatory filings, and demonstrated working knowledge of FDA , ICH, ... packaging, compatibility characterization for processing and administration, and supporting regulatory filings.Collaborate with key stakeholders across the organizations (Research… more
- Merck & Co. (Rahway, NJ)
- …supply chain efficiencies, and improve product stewardship practices, while ensuring compliance with regulatory requirements.6. Foster a culture of excellence, ... continuous improvement activities that ensure the safety, effectiveness, and compliance of the company's products.- The organization will ensure post-market… more
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