- Contract Pharmacal Corp (Hauppauge, NY)
- …Knowledge & Abilities + Knowledge of cGMPs, US FDA , and EU/EMEA regulatory requirements + Familiarity with Quality System standards, ICH guidelines, USP, and ... presses. + End-to-end impact - take ideas from early development through regulatory submission and commercialization. + Collaborative environment - partner with R&D,… more
- CSL Behring (King Of Prussia, PA)
- …strategy into clinical development plans (CDPs), target product profiles (TPPs), and regulatory submissions. + Ensure high- quality statistical input into study ... and regulatory documentation. + Represent Biostatistics in interactions with regulatory authorities (eg, FDA , EMA, PMDA) and contribute to preparation… more
- Merck (Wilson, NC)
- …statistical software packages (Minitab or JMP) + Experience supporting regulatory inspections including FDA **Required Skills:** Adaptability, Adaptability, ... vaccines filled at the Wilson site consistently meet critical quality attributes + Act as or support technical subject...Act as or support technical subject matter expert(s) during regulatory inspections for area of assignment + Ensure that… more
- CSL Behring (King Of Prussia, PA)
- …Role** + Maintain PV data standards, taxonomies, and controlled vocabularies with global regulatory requirements (eg, ICH, EMA, FDA ) + Lead governance of PV ... pharmacovigilance (PV) data and processes. You will ensure compliance, consistency, and quality in safety data management across the R&D organization, supporting … more
- Oracle (Helena, MT)
- …customer expectations, and industry best practices. + Guide the integration of regulatory and quality requirements into software development practices and ... designing, optimizing, and governing software development processes to deliver high- quality , compliant, and effective healthcare technology solutions. This role… more
- Lilly (Indianapolis, IN)
- …effective relationships and alignment with Lilly partners external to DDCS (eg Quality , Manufacturing, Regulatory , Digital Health, Business Units) + Build strong ... coming years. In response to this growing portfolio and increasing global regulatory expectations, the DDCS organization requires a Design and Human Factors… more
- Sanofi Group (Morristown, NJ)
- …leading and overseeing all statistical work for clinical development and regulatory submissions, leading a team focused on clinical development strategies, ... Head partners closely with clinical teams, Clinical Sciences & Operations (CSO), regulatory experts, and key stakeholders to accelerate the delivery of medicines to… more
- Charles River Laboratories (Hollister, CA)
- …and ensure compliance with regional, state and federal safety and environmental regulatory agencies. + Maintain and ensure timely reporting of safety and ... environmental data, documentation, permits and licenses to all applicable regulatory agencies. Assess new regulatory standards and...leader in the production and distribution of the highest quality research animal, with 1 out of 2 animal… more
- Lilly (Indianapolis, IN)
- …+ Familiarity with LNP formulation and drug product considerations. + Strong regulatory interaction experience ( FDA , EMA, other health authorities). Lilly is ... multidisciplinary group that works collaboratively with our discovery, manufacturing and quality , business units. **Position Summary** We are seeking a Senior… more
- System One (Fairfield, NJ)
- …Microbiology Manager with strong microbiology skills and the ability to lead quality efforts on the production floor. This role supports daytime operations through ... microbiological testing, analytical checks, and direct oversight of line quality activities. Candidates must bring at least 5+ years of QA/QC experience, advanced… more