- Eisai, Inc (Exton, PA)
- …life cycle activities and deliverables.Minimum of 3 years work experience with pharmaceutical regulatory compliance and global regulations for computerized ... and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong… more
- Turner & Townsend (Marietta, PA)
- …across all stakeholders, ensuring transparency and owner oversight. Ensure compliance with contractual obligations, regulatory requirements, and organizational ... Description** **Turner & Townsend** are seeking an ambitious construction **Senior Change Manager ** to join our growing Life Science team. The ideal candidate is… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …assigned project teams, to ensure Otsuka's products are developed/maintained in compliance with global regulatory requirements and guidances. Primary ... all CMC and GMP related documents for submission to regulatory authorities to assure compliance with ...programs (Word, Excel, PowerPoint, and Outlook). + 7-years CMC regulatory experience in the pharmaceutical industry with… more
- Teva Pharmaceuticals (West Chester, PA)
- …or a department that works closely with RA including Quality Assurance, Regulatory Compliance , Regulatory Operations, Quality Control, Program Management, ... Manager , Regulatory Affairs Date: May 5,...a Master's degree in the specified fields. Must have biotech/ pharmaceutical industry experience with: + GXP including cGMP practices… more
- Grifols Shared Services North America, Inc (Harrisburg, PA)
- …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
- Lilly (Philadelphia, PA)
- …to make life better for people around the world. Responsibilities: The Associate / Manager , CMC Regulatory and IMP Manufacturing Operations is a hybrid role ... Development supporting the two functional areas. The Associate / Manager is responsible for CMC regulatory operations,...and assessments, as well as task management to ensure compliance with quality management systems + CMC regulatory… more
- Lilly (Philadelphia, PA)
- …solutions to support communities through philanthropy and volunteerism. **Position Overview:** The Manager - CMC Regulatory is responsible for the preparation ... and delivery of high-quality CMC regulatory submissions. This position supports Lilly/Avid diagnostic radiopharmaceutical marketed products globally.… more
- Sumitomo Pharma (Harrisburg, PA)
- …a dynamic, highly motivated, and experienced individual for the position of **Associate Manager , Compliance , Training & Strategic Alliance (CTSA), PVRM** . The ... Associate Manager , Compliance , Training & Strategic Alliance (CTSA),...- 3 years of relevant experience in biotech or pharmaceutical industry specific to Pharmacovigilance operations and compliance… more
- United Therapeutics (Harrisburg, PA)
- …culture of compliance with confidence and enthusiasm. The Senior Corporate Compliance Manager - Training, Communications and Policy will be responsible for: ... training and communication Minimum Requirements + 10+ years of experience in compliance in the life sciences industry: pharmaceutical , medical or biotech with… more
- University of Pennsylvania (Philadelphia, PA)
- …participate in the coordination of Phase I-V clinical trials. Reporting to the Regulatory Affairs Research Teams Manager , the Regulatory Affairs ... He/she will, with minimal supervision, prepare and process all required regulatory documentation for pharmaceutical companies, contract research organizations… more
