- Merck (Rahway, NJ)
- …validation support, preparation of Chemistry, Manufacturing, and Controls (CMC) documents for global regulatory submissions, and responses to regulatory ... validation + Familiarity with authoring relevant CMC sections of regulatory submissions Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld) Current Contingent… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …Oversee the process validation lifecycle (PPQ, CPV, etc.) ensuring compliance with global regulatory standards. + Establish and oversee robust Continued Process ... appropriate. + Collaborate with cross-functional teams including R&D, Quality Assurance, Regulatory Affairs, and Operations to align strategies and optimize product… more
- ConvaTec (NJ)
- …Synthesize key reimbursement activities globally in dashboard format. + Analyze global legislative and regulatory changes to anticipate reimbursement challenges ... trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of… more
- Sumitomo Pharma (Trenton, NJ)
- …Interface with regulatory authorities, including the FDA, EMA, and other global agencies, to secure trial approvals and navigate the regulatory landscape. ... data and present findings clearly. + Significant experience with global clinical trials and regulatory process. + Credibility within the global medical… more
- Hovione (East Windsor, NJ)
- …agreements and licensing agreements and combinations thereof. * Coordinate with the global regulatory , production, and R&D groups to provide a superior ... product development * Possess solid knowledge of pharmaceutical cGMP and regulatory requirements * Good communication skills (verbal and written) * Proactive,… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …leads, clinical development, global value and real-world evidence, US and global commercial teams, market access, and regulatory affairs, to ensure ... **Company Overview:** Otsuka is a global healthcare company driven by our purpose "to...and strong competency with the US healthcare system and regulatory landscape is required for this role. + Stay… more
- Bristol Myers Squibb (Princeton, NJ)
- …Medicine group + Represents Translational Medicine on cross-functional strategy and global project teams + Supports regulatory submissions, regulatory ... translational data generated to support asset development and contribute to regulatory submissions. This individual will work on cross-functional project teams to… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …or external reviews including ensuring alignment with Gilead business needs and regulatory requirements. + Stay current with evolving global PV regulations ... audits, in the biopharma or related industry. + Proficiency in pharmacovigilance regulatory requirements ( Global ) is a must. + Expert-level experience working… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …10+ Years with MS/MA or MBA **PREFERRED QUALIFICATIONs:** + Proficiency in clinical regulatory requirements ( Global ) is a must. + Expert-level experience working ... improvements in R&D quality processes, systems, and standards to meet regulatory requirements and organizational goals and contribute to the overall quality… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …guidance to support business strategies. + Work cross-functionally with Global Transportation, Procurement, Master Data Organization, Regulatory , Distribution ... makers of possible** BD is one of the largest global medical technology companies in the world. Advancing the...SME's for HTS classification and required PGA data from Regulatory . + Assess accuracy of commercial invoice(s) to comply… more