- West Pharmaceutical Services (Exton, PA)
- …Attention to detail with planning, time management and organizational skills + Regulatory compliance competency including Quality Systems + Experience with ... Senior Specialist, Regulatory Affairs Requisition ID: 69746 Date: May 13,...addition, the Sr. Specialist mentors team members and ensures compliance with West Pharmaceutical Services, Inc. (West)… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …complex submissions to various governmental agencies and ensure contents are in compliance with domestic and international regulatory requirements. + Prepare ... regulatory experience. + Minimum 4 years of related technical and/or regulatory experience in pharmaceutical industry + Experience with the pre-clinical,… more
- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- …+ Escalate to management urgent and time-sensitive matters that impact regulatory compliance . + Maintain files contemporaneously for transparency and ... (eg, Pharmacy, Chemistry, Biology). + Preferred two (2) years related technical and/or regulatory experience in pharmaceutical or blood industry. + Depending on… more
- Takeda Pharmaceuticals (Lexington, MA)
- …and guidelines. Apply and adapt this understanding to projects to enhance probability of regulatory success and regulatory compliance . Ability to draw from ... and efficiencies. + As a GRA CMC member, ensures and / or enhances regulatory compliance . + Ensures project team colleagues, line management, and key… more
- Grifols Shared Services North America, Inc (Fort Worth, TX)
- …Knowledge and understanding of FDA regulations for the biotechnology and pharmaceutical industry. Understanding of global regulatory regulations. Excellent oral ... Regulatory Affairs or related field within the Biologics, Biotech or Pharmaceutical industry. Sound basis of regulatory knowledge. Ability to write… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …ICH guidelines; + cGMP standards; + Federal and State laws related to pharmaceutical regulatory affairs; + Business, scientific and personal computer software ... test methods, etc. + Implement policies to assure on-going compliance of Regulatory Affairs activities. + Assess...Pharmaceutics or a related field and 3 years of regulatory experience with a pharmaceutical company. Must… more
- Boehringer Ingelheim (Ridgefield, CT)
- …execution of regulatory activities required of an IND/NDA/BLA Holder for compliance to FDA requirements for BI's investigational and US market product portfolio. ... of all regulatory activities required of an IND/NDA/BLA Holder for compliance to FDA requirements for BI's investigational and US market product portfolio. These… more
- West Pharmaceutical Services (Exton, PA)
- …customers with West product compliance information and data as required for regulatory compliance and submissions to North America, Europe, and Rest of World ... **Job Summary** The Sr. Specialist, Regulatory Affairs evaluates supplier regulatory declarations for compliance , authors and maintains material … more
- Bausch Health (Bothell, WA)
- …changes. **Risk Management and Reporting** + Conduct risk assessments related to regulatory compliance , helping the company identify potential non- compliance ... Join a team! We are a global diversified pharmaceutical company enriching lives through our relentless drive...highlighting regulatory achievements and potential risks. **Global Regulatory Compliance ** + Ensure compliance … more
- Sanofi Group (Morristown, NJ)
- …as appropriate. **About you** **Experience** : + 1+ year of experience in Regulatory Affairs in the Pharmaceutical industries. + Experience in Global ... ** Regulatory Strategist - VIE Contract** + _Location: United...Authorities questions, labeling changes, risk minimization measures). + Maintain compliance with all internal and external requirements and procedures… more