- Gilead Sciences, Inc. (Foster City, CA)
- …Development & Manufacturing (PDM) and partner with Quality, Supply Chain, Manufacturing, CMC Regulatory Affairs , Clinical Development and Technical ... a state-of-the-art analytical laboratory + Guide the authoring, review and approval of CMC sections in regulatory filings, and support interactions with health… more
- Takeda Pharmaceuticals (Lexington, MA)
- …and program management experienced in leading cross-functional clinical programs within Medical Affairs , Clinical Research, Regulatory , CMC or other drug ... phases of development with significant experience within related functions (eg, Medical Affairs , Clinical Operations, Regulatory , CMC , Marketing). + Minimum… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …independently, as needed + Partners cross-functionally with departments such as Regulatory Affairs , Toxicology, CMC /Formulations, Biostatistics, Legal, ... documents (ie protocols, Investigator's Brochures, clinical study reports, summaries for regulatory submissions). The Director , Clinical Development will provide… more
- Organon & Co. (Sacramento, CA)
- …colleagues in preclinical science, data science, clinical operations, regulatory affairs , chemistry, manufacturing and control ( CMC ), project management and ... in the US + There are **2 openings** The Director , Clinical Pharmacology Lead will be responsible for contributing...are sound, based on the most up-to-date literature and regulatory guidance and support the approved early development plans.… more
- AbbVie (North Chicago, IL)
- …Commercial, Global Supply Chain, Domestic and International AbbVie Plants and Affiliates, Regulatory Affairs , R&D, and S&T to align strategic initiatives. ... Develop regulatory strategies for brands with Regulatory Affairs . Responsibilities List up to 10 main responsibilities for the job. Include information about… more
- Bausch Health (Newark, NJ)
- …Project Management, CMC , Analytical Sciences, Nonclinical, Clinical Operations, Clinical/Medical Affairs , Biostatistics, and Regulatory Affairs . + Lead ... it-where your skills and values drive our collective progress and impact. The Director of Clinical Pharmacology will provide expertise and support to internal and… more
- Surrozen (South San Francisco, CA)
- …with multidisciplinary teams including preclinical development, biostatistics, clinical operations, quality, regulatory affairs and CMC . As leader of ... AMD/uveitic macular edema (UME). Reporting directly to the CEO, the Exec. Director /VP Clinical Development will contribute to and lead early clinical programs in… more
- University of Maryland, Baltimore (Baltimore, MD)
- …in the MS in Regulatory Science program, with a focus on introductory and regulatory affairs aspects of the program, as well as another aspect of the program ... AREAS OF EXPERTISE AND EXPERIENCE_* Regulatory science, including introductory and regulatory affairs aspects, as well deep knowledge in another aspect (eg… more
- Vera Therapeutics (Brisbane, CA)
- …regulatory content that meets current regional requirements * Represent clinical Regulatory Affairs on cross-functional project teams * Evaluate proposed ... * Experience communicating regulatory strategies to stakeholders * Demonstrated Regulatory Affairs experience commensurate with the role * Industry… more
- UTMB Health (Galveston, TX)
- …and related to appropriate compliance with Medicare and Medicaid statutory and regulatory requirements. + Supports UTMB Legislative Affairs department with ... Director of Finance Government Reimbursement (Medicare, Medicaid) -...quarterly reimbursement estimates and annual cost reports provided to UTMB- CMC staff related to TDCJ patient services. + Represents… more