- System One (Florham Park, NJ)
- …effectively in a cross-functional team environment. + Strong knowledge of regional regulatory requirements and guidelines, including FDA regulations and ICH ... Job Title: AD or Director, Regulatory Affairs Strategy Location: Florham Park, NJ (10...IND applications and 1 NDA) + Knowledge of and Compliance with FDA , EMEA, PMDA guidances +… more
- Robert Half Finance & Accounting (Morristown, NJ)
- …are looking for a dedicated Associate to play a key role in ensuring compliance with quality and regulatory standards within the pharmaceutical industry. Based ... and driving quality management initiatives. Responsibilities: * Ensure adherence to FDA Good Manufacturing Practices (GMP) and other regulatory standards… more
- Edgewell Personal Care (Allendale, NJ)
- …This role combines strong analytical capabilities with a deep understanding of compliance , quality metrics, and regulatory requirements. The analyst will lead ... Chain, Quality Assurance, Regulatory Affairs, or Operations Analytics + Exposure to regulatory standards such as FDA , EU MDR, ISO 13485 or GMP preferred… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …Oversight: Offer strategic regulatory advice to cross-functional teams and ensure compliance with FDA , EMA, and Health Canada regulations. Assess ... strategies for Biologics, Biosimilars, and Small Molecules.Ensure alignment with regulatory trends, innovation, and compliance while balancing business benefits… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …relevant experience. + BA/BS with 10+ years' relevant experience. + Significant regulatory , quality, compliance or related experience in the biopharma industry. ... Other Requirements** + In-depth understanding of US Food & Drug Administration ( FDA ) and European Medicines Agency (EMA) regulatory requirements and… more
- Grifols Shared Services North America, Inc (Trenton, NJ)
- …more than 110 countries and regions. **Summary:** Develops and implements worldwide regulatory programs for marketed products and/or those for development, and has ... interactions with regulatory authorities to expedite approvals. Participate in the development of, and leads/executes regulatory strategy and tactical decisions… more
- Sanofi Group (Morristown, NJ)
- …consistency between core and local market labeling; collaborate with regional /country regulatory teams to address labeling implementation or compliance issues. ... on organizational structure. **About You** **COMPETENCES** + Strong knowledge of global regulatory labeling requirements ( FDA , EMA, ICH) and lifecycle labeling… more
- Kelly Services (Bridgewater, NJ)
- ** Regulatory Specialist - Ad Promo (Pharma/Consumer Health)** **Location:** Remote **Contract Length:** 6 months **Pay Rate:** $70-$100/hour **Schedule:** ... Monday-Friday, 8am-5pm ET (preferred) We are seeking a Regulatory Specialist with strong advertising and promotion (Ad Promo) experience to support a leading… more
- embecta (Parsippany, NJ)
- …and operations comply with internal standards and regulatory requirements, including FDA and ISO standards. The Quality Compliance Auditor plays a strategic ... of continuous improvement while driving adherence to quality and regulatory expectations across the organization. This role will be...+ Monitor the Quality Management System (QMS) to ensure compliance with FDA regulations, ISO 13485, ISO… more
- Vitalief (New Brunswick, NJ)
- …qualifying trial per CMS regulations, and assesses compliance with other regulatory requirements, including FDA and NIH guidelines. + Negotiates budgets with ... trial billing administrative start-up, insuring clinical research billing and regulatory compliance . Collaborate with Finance to coordinate documentation… more