- ThermoFisher Scientific (Pittsburgh, PA)
- …making a meaningful impact on global health and scientific advancement. As a Senior Regulatory Affairs Specialist, you'll provide strategic guidance on ... or Bachelor's Degree plus 8 years of experience in regulatory affairs in the pharmaceutical, medical device,... scientific field. + Additional certifications like RAC ( Regulatory Affairs Certification) advantageous + Experience with… more
- West Pharmaceutical Services (Exton, PA)
- Senior Regulatory Affairs Specialist...of data and or reports to be incorporated into regulatory submissions to ensure scientific rigor, accuracy, ... PA, US Rockford, AZ, US Scottsdale, AZ, US Department: Regulatory Affairs Description: **This is a hybrid...documents. + Ability to review, collate, describe, and summarize scientific and technical data. + Ability to organize complex… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- **Job Summary** The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global ... relationships with other local and/or global functional units [OPC CMC Global Regulatory Affairs , Global Regulatory Strategy, Manufacturing facilities,… more
- Parexel (Harrisburg, PA)
- …global regulatory teams; facilitate timely endorsement of labeling decisions by senior leadership. + Interpret clinical and scientific data to inform ... seamlessly both internally and externally on compliance matters. + Proficient regulatory knowledge, including scientific concepts within labeling and their… more
- Dentsply Sirona (York, PA)
- …channels, enhancing business relationships. + Manages day to day activities for less senior Regulatory Affairs professionals, including but not limited to ... degree in a relevant field, such as life sciences, regulatory affairs , or a related discipline. +...Affairs Professionals Society) or Master's degree in a scientific discipline is a plus. Years and Type of… more
- GRAIL (Harrisburg, PA)
- …products with the FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing submissions such as PMAs, 510(k)s, post-approval ... and leadership. They may manage and provide direction to regulatory staff and, when required, participate in senior...of Standard Operating Procedures and policy guidelines within the regulatory affairs department. + Perform other duties… more
- Edwards Lifesciences (Allentown, PA)
- …Senior Manager (formal internal title is Senior Manager, Medical Affairs ) is responsible for providing scientific expertise throughout the development and ... scientific documents (as appropriate). + Independently author complex regulatory responses. + Perform systematic literature reviews from initiation to completion… more
- Sumitomo Pharma (Harrisburg, PA)
- …highly motivated, and experienced individual for the position of **Associate Director, Regulatory Affairs (Oncology).** The Associate Director is part of the ... Global Regulatory Affairs (GRA) team based in the...Comfortable presenting to all levels of the organization including Senior Management. **Education and Experience** + Bachelor's degree in… more
- Teleflex (Wyomissing, PA)
- …The Senior RA Associate will partner with Product Management Regulatory Affairs personnel to support 510(k)s, Canada License applications, European ... Sr. Regulatory Affairs Associate **Date:** Dec 23,...Experience Requirements** * A bachelor's degree, preferably in a scientific discipline such as biology, microbiology, chemistry, engineering, or… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- As a senior leader within Medical Affairs , the Executive Director will serve as a strategic thought partner and Chief of Staff to the Vice President of Medical ... capabilities within a biotech or pharmaceutical setting + Expertise in navigating regulatory frameworks and ensuring compliance within medical affairs function +… more
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