- University of Pennsylvania (Philadelphia, PA)
- …Description Summary This entry-level position will support the faculty and clinical research staff of the Department of Medicine in the preparation for, conduct of, ... requires significant dedication and resilience to acquire and apply regulatory knowledge with the duty to protect research patient...to protect research patient safety and data integrity. The staff member will complete all tasks delegated by the… more
- Otsuka America Pharmaceutical Inc. (Santa Fe, NM)
- …including INDs, IBs, clinical study reports, and NDAs/BLAs. + Collaborate with regulatory affairs on interactions with global health authorities. + Provides ... to post commercialization, with emphasis on the large global clinical trials and regulatory filing activities. The Senior Director, GCD is responsible for all the… more
- Abbott (Sylmar, CA)
- …+ Minimum 8 years experience of Quality Systems, Quality Assuance and/or Regulatory Compliance/ Affairs experience in In Vitro Diagnostics and medical device ... role** . Sets strategy for internal, clinical, and external audits ( Regulatory Agencies, Corporate, Certification bodies, and major clients) ensuring sites are… more
- City National Bank (Phoenix, AZ)
- …interacting with regulatory agencies, including exam management and other regulatory affairs . * For Banking Compliance related roles, Certified Compliance ... ensuring controls are in place to mitigate compliance risk. Maintaining regulatory change management, policies and procedures, training, and advisory matters for… more
- Xeris Pharmaceuticals, Inc. (Chicago, IL)
- …Collaborates with other external functions on CMC matters (eg, Quality, Commercial, Regulatory Affairs , etc.). Ensures the CMC function is adequately represented ... and standards in preparation for post-approval changes and submission of Regulatory Market Approvals by USFDA and other Health Authorities. This expertise… more
- South Jersey Industries (Atlantic City, NJ)
- … agencies, other departments and external customers in the support of regulatory affairs and pricing objectives. Essential Duties and Responsibilities: + ... and others as requested. + Provide information directly to BPU Staff and other regulatory stakeholders as needed to conduct the position duties. + Act… more
- American Electric Power (Washington, DC)
- …and other regulatory matters. + In collaboration with FERC/RTO Policy, Federal Affairs , and Regulatory groups, advise on regulatory matters under the ... experience preferably with a law firm, corporate legal department, or on the staff of a rate regulatory body, such as FERC or a state regulatory agency.… more
- Genentech (South San Francisco, CA)
- …will have strong collaboration with cross-functional teams, including clinical research, regulatory affairs , and product development, to ensure the successful ... require a strong understanding of cardiovascular diseases, clinical trial protocols, regulatory requirements, and possibly interactions with regulatory agencies… more
- University of Pennsylvania (Philadelphia, PA)
- …will also require an accurate, complex-level documentation for internal and regulatory reporting following Good Documentation Practices. Demonstrated expertise as an ... to ensure data is accurate, logical, and consistent with institutional and regulatory reporting requirements. The PDE Manager, with minimal direction, is expected to… more
- UPMC (Butler, PA)
- …of Radiation Therapy (https://mycareer.upmc.com/the-lasting-impact-of-radiation-therapy/) . Responsibilities: + Regulatory Affairs Management: Champions and ... and provides meaningful insight and feedback to ensure compliance with all regulatory groups. Facilitate CPR recertification for staff . Risk Master reporting… more