- Bausch + Lomb (Sacramento, CA)
- …global team members, other B&L departments (eg, R&D/Project Management, Clinical/Medical Affairs , Biometrics, Regulatory Affairs , Quality Assurance, ... in an accurate and timely manner. + Provide Clinical Operations support to the Regulatory Affairs department. Leadership: + Manage in-house team of CRAs, CTAs… more
- Cardinal Health (Sacramento, CA)
- …medical affairs professionals who report to the Sr Director of Regulatory & Medical Affairs . **Responsibilities:** + Collaborate across multiple functions ... hours. We also provide customers the support they need in regulatory compliance, reimbursement, continuing education, information management and other crucial areas,… more
- Unilever (El Segundo, CA)
- …cross functional collaboration within all levels of the business but in particular with Regulatory Affairs as well as our partners at Universities and CROs. The ... related topics to ensure up to date substantiation + Work closely with Regulatory Affairs to develop claims derived from trials + Creation of marketing friendly… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …decision, as applicable. + Collaborates with leadership in Business Unit Quality, Regulatory Affairs , R&D, Operations, Service, Medical Affairs , Legal, ... creation and management of communications with FDA and other regulatory agencies, 2) ensuring that commitments made to the...ensuring that commitments made to the FDA and other regulatory agencies (eg, recall letters) are implemented at the… more
- Envista Holdings Corporation (Brea, CA)
- …Manage the submission process for marketing materials requiring review and approval from Regulatory Affairs and Legal Affairs , ensuring all assets comply ... and regional marketing teams, creative agencies, and internal departments (including Regulatory and Legal) to ensure seamless communication and efficient project… more
- Actalent (Irvine, CA)
- …teams to align SOPs with business and compliance needs. + Partner with Regulatory Affairs to ensure claims meet global regulatory requirements. ... (Master's preferred). + 8-10 years of experience in Quality Systems or Regulatory Affairs within the medical device industry. + Strong understanding of FDA… more
- UCLA Fielding School of Public Health (Los Angeles, CA)
- …and knowledge of FDA regulatory pathways. * ACRP certification, expertise in regulatory affairs and regulatory submissions, IND filings, engagement with ... of FDA regulatory pathways. * ACRP certification, expertise in regulatory affairs and regulatory submissions, IND filings, engagement with the FDA,… more
- BeOne Medicines (San Mateo, CA)
- …The ideal candidate will have a strong background in research, clinical development, regulatory affairs , and safety, with a particular focus on process ... focus on R&D. + Proven expertise and understanding of research, clinical development, regulatory affairs , and safety processes, workflows and analytics. + Strong… more
- Abbott (Sylmar, CA)
- …+ Facilitates regulatory submissions and communications by communicating with Regulatory Affairs during the submission process. + Participates in and ... and cross-functional teams in order to develop clinical strategy. Interacts with regulatory agencies as needed, and will use their scientific and medical knowledge… more
- Grifols Shared Services North America, Inc (Los Angeles, CA)
- …sciences or related field. + Minimum 5 years' experience in Quality Assurance, Regulatory Affairs , Compliance, Quality Engineering or Quality Control, in the ... Summary:_ Write, review and approve submissions to the FDA and other regulatory agencies and coordinate completion of the technical documentation required to meet… more
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