- Cardinal Health (Boston, MA)
- …submissions as well as clinical research and manufacturing process consulting. Regulatory Affairs plans, coordinates and implement regulatory strategies ... **_What Regulatory Affairs contributes to Cardinal Health_**...in the Waukegan, IL location.** **Responsibilities** + Interpret complex regulatory requirements (eg, FDA 21 CFR Part… more
- CSL Behring (Waltham, MA)
- …(PST) and/or related global R&D/commercial teams, plus leads the corresponding Global Regulatory Affairs Strategy Team (GRAST) ensuring connectivity, 'One GRA ... or EMA) and maintaining productive relationship and driving positive regulatory outcomes with both FDA & EMA...one key region (EU, US, Japan) *Experience working in Regulatory Affairs with agency interaction responsibility with… more
- Orchard Therapeutics (Boston, MA)
- …collaboration with Clinical Operations, Data Management, Biostatistics, Regulatory , Medical Affairs , Pharmacovigilance and other teams supporting ... development, the clinical development plans, managing the clinical studies, drive the regulatory documentations/presentations, writing and executing… more
- Parexel (Boston, MA)
- …colleagues, GCTO Country Operations, other GCTO functional areas, Pharmacovigilance (PV), Global Regulatory Affairs (GRA), IT, etc.) is fully informed and ... regulatory inspection knowledge as it relates to Good Clinical Practice (GCP) inspections by regulatory agencies...Contact (POC) for a specific area of regulations (eg FDA , EMA, NMPA, etc.). As such, the Clinical… more
- Takeda Pharmaceuticals (Lexington, MA)
- …as clinical liaison to Global Device Team, including engineering, regulatory affairs , quality, and commercial functions + Coordinate interdepartmental ... principles, while fostering collaboration across multidisciplinary teams to deliver device clinical outcomes that exceed quality benchmarks and regulatory … more
- Sanofi Group (Cambridge, MA)
- …endpoint strategy implementation + Knowledge of the drug development process and the regulatory ( FDA , EMA, local agencies) and payer (EUnetHTA, NICE, HAS, G-BA, ... **Job Title:** Senior Clinical Outcomes Assessment (COA) Lead **Location:** Cambridge, MA,...instruments; the development of briefing books or dossiers for regulatory consideration of COAs Internal customers include primarily Research… more
- Takeda Pharmaceuticals (Boston, MA)
- …experience in GCP Quality/Compliance. + Advanced knowledge of pharmaceutical development, medical affairs and GCP/GVP regulations including FDA , EU, MHRA, PMDA ... + Experience must include successful development and implementation of a clinical or pharmacovigilance audit program, hosting/leading regulatory inspections,… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …applicable to the design, analysis of clinical trials and process for regulatory submissions across difference regions (ICH, FDA , EMA and others). + Advanced ... Clinical Sciences, Outcomes, Digital Health, Pharmaceutical Sciences/Device, and Global Regulatory Affairs . + Advanced knowledge of regulatory guidance… more
- Sanofi Group (Cambridge, MA)
- …strategy with the global project team and internal partners, such as clinical operations, translational medicine, regulatory affairs , biostatistics, drug ... SOPs, GCP, ICH guidelines and other regulations + Review documents supporting clinical development such as Investigator's brochure, regulatory documents for IND… more
- ConvaTec (Lexington, MA)
- …Study Co-ordination, Data Analytics), Evidence Genertion, R&D External - Vendors, Clinical Sites, Regulatory approvers ( FDA , Competent Authorities, ... of education. **Dimensions:** **Principal Contacts & Purpose of Contact** Internal - Medical Affairs , Clinical Operations (Study Management, Site Management,… more