- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …and/or review technical reports, protocols, risk assessments, and relevant sections of regulatory submissions (IND, BLA, MAA, etc.) related to upstream processing. + ... Collaborate closely with Downstream MSAT, Validation MSAT, QA, Regulatory , Process Development, and CDMO technical teams. + Stay current with advancements in… more
- The Hershey Company (Hershey, PA)
- …Collaborate with OBD, Marketing, Brand, and Customer teams, Finance, legal and regulatory and all functions within the process (procurement, manufacturing plants and ... Create Hershey standard operating procedures for pre-press contractor personnel (eg Regulatory compliance) * Ensure quality documents related to Hershey graphics… more
- Deloitte (Pittsburgh, PA)
- …technologies like GenAI, AI/ML, and automation for analytical methods, manufacturing, regulatory and/or QA/QC + Implementation of regulatory authoring tool(s) ... Q9, Q10), FDA/EMA/PMDA regulations, and the structure/content of CMC sections in regulatory submissions (IND, NDA, BLA, MAA) + 1+ years experience leading, managing… more
- UPMC (Pittsburgh, PA)
- …consistent with Schools of Nursing standards, requirements of the respective regulatory and accrediting agencies and system-wide quality standards. The Director is ... consistent with Schools of Nursing Standards, requirements of the respective regulatory and accrediting agencies and system-wide quality standards. The Director is… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …for assigned areas. Knowledge and strong competency with the US healthcare system and regulatory landscape is required for this role. + Stay abreast of the latest ... and real-world evidence, US and global commercial teams, market access, and regulatory affairs, to ensure integrated global strategies and cohesive medical affairs… more
- UPMC (Farrell, PA)
- …Such procedures are carried out in accordance with established policies, regulatory guidelines and patient safety protocols. + Makes appropriate referrals in ... with the attending physician for medical consultations, supportive services and regulatory reporting of patient safety issues. + Provides support as well… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …process validation lifecycle (PPQ, CPV, etc.) ensuring compliance with global regulatory standards. + Establish and oversee robust Continued Process Verification ... appropriate. + Collaborate with cross-functional teams including R&D, Quality Assurance, Regulatory Affairs, and Operations to align strategies and optimize product… more
- Langan Engineering, Environmental, Surveying and Landscape… (Philadelphia, PA)
- …conduct IH surveys; + Perform risk assessments and audits to verify regulatory compliance and industry best management practices for external industrial and legal ... from incidents; + Develop engaging health and safety trainings to be regulatory compliant and site specific; + Review and interpret industrial hygiene results… more
- System One (Pittsburgh, PA)
- …figures, and listings (TFLs) for clinical trial publications and regulatory submissions. + Collaborate with cross-functional teams, including clinical investigators, ... accessible manner to stakeholders. + Ensure all statistical work complies with relevant regulatory guidelines (eg, FDA, EMA) and Good Clinical Practices (GCP). + Use… more
- Colliers Engineering & Design (Philadelphia, PA)
- …& Sedimentation Pollution Control (E&SPC) Best Management Practices (BMPs), and other regulatory items. A Senior Engineer will work within AutoCAD Civil 3D as ... NPDES permits, General Permits, and other technical aspects of the regulatory permitting process. + Develop Erosion & Sedimentation Pollution Control (E&SPC)… more