- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- … strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in alignment ... of the drug development process, laws, regulations, and guidelines including FDA , ICH, etc. - Able to successfully interpret and apply regulatory … more
- Merck (Rahway, NJ)
- …quality and compliance across all documentation. + Interact independently with regulatory agencies ( FDA , EMA, etc.), including leading meetings, teleconferences, ... BS in biological sciences, chemistry, or related discipline with 10+ years of relevant drug development, clinical, or regulatory experience. + MS with 10+ years… more
- Merck (Trenton, NJ)
- …quality and compliance across all documentation. + Interact independently with regulatory agencies ( FDA , EMA, etc.), including leading meetings, teleconferences, ... in biological sciences, chemistry, or related discipline with 10+ years of relevant drug development, clinical, or regulatory experience. + MD or Ph.D./Pharm D… more
- System One (Florham Park, NJ)
- …Overview: This role will support in the preparation and submission of electronic regulatory documents through the FDA and Health Canada Electronic Submission ... of nonclinical, clinical, CMC, DMF, and labeling/SPL submission documents. + Familiar with regulatory guidelines, such as FDA , EMA, MHRA, and Health Canada.… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Requirements** + In-depth understanding of US Food & Drug Administration ( FDA ) and European Medicines Agency (EMA) regulatory requirements and International ... create possible, together. **Job Description** You will act as the Regional Regulatory Lead on more complex or multiple products, compounds, indications or projects… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …strategic regulatory advice to cross-functional teams and ensure compliance with FDA , EMA, and Health Canada regulations. Assess regulatory impact of changes ... regulatory processes. Additional Responsibilities: + Maintain awareness of all regulatory activities regarding new and approved drug products. Stay current… more
- Sanofi Group (Morristown, NJ)
- …on organizational structure. **About You** **COMPETENCES** + Strong knowledge of global regulatory labeling requirements ( FDA , EMA, ICH) and lifecycle labeling ... **Job Title:** Director, Global Regulatory Affairs - Global Labeling Strategy **Location** :...of medicine? The race is on to speed up drug discovery and development to find answers for patients… more
- Integra LifeSciences (Plainsboro, NJ)
- …patient outcomes and set new standards of care. The **Internal Auditor, Regulatory Compliance** will have an in-depth understanding and knowledge of appropriate GMP ... on-going project support and governance, as assigned. + Provide support for regulatory inspections, input to responses and corrective action plans and ensure the… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Director, US Regulatory Affairs - Advertising and Promotion **Location:** Cambridge, MA or Morristown, NJ **About the job** Are you ready to shape the ... future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in… more
- Merck (Rahway, NJ)
- …+ Deep and broad working knowledge of pharmaceutical vaccine/biologic/small molecule drug product and process development including regulatory submission and ... & Technology (DD&T) organization designs, develops, and commercializes novel biologic/ drug / vaccine - device enabled combination products to achieve safe and… more
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