- Regeneron Pharmaceuticals (Warren, NJ)
- …compound(s) including mechanism of action and drug landscape as well as maintaining compliance in accordance with FDA, EMEA, ICH and GCP guidelines as well as ... Clinical Study Reports with minimal guidance and supports the development of regulatory documents; performs quality review and may approve; adjudicate and resolve… more
- AbbVie (Chicago, IL)
- …evidence partnership, communication and dissemination. + Collaborates with HTA and Regulatory teams to develop evidence packages for submission + Drive enterprise ... area strategy that effectively and efficiently meets ethical, scientific, regulatory , commercial, and quality requirements + Accountable for end-to-end delivery… more
- Integra LifeSciences (Plainsboro, NJ)
- …all appropriate documentation, drawings, and specifications are generated in compliance with Integra's procedures and statutory requirements. + Initiate, develop ... technical investigations and provide practical manufacturing solutions, under appropriate regulatory guidelines for Medical Device Manufacture. As required, conduct… more
- J&J Family of Companies (Raritan, NJ)
- …essential for enabling the CARVYKTI network's technical, supply chain, and compliance -related objectives. Collaborating across a complex network of internal and ... aimed at reducing non-conforming product rates, through projects that may/may not require regulatory approval + Provide technical support to regulatory filings, … more
- Lilly (Pleasant Prairie, WI)
- …inspection readiness and execution. This role has direct interaction with Regulatory Agencies during site inspections. + Manage external contracts/resources and ... documentation including procedures, deviation investigations, technical reports, change controls, regulatory submissions, validation master plans, protocols and summary reports,… more
- Abbott (Maple Grove, MN)
- …and mock shells, in alignment with the team. + Collaborate with clinical, regulatory , and data management teams to define data checking requirements and resolve ... discrepancies. + Support regulatory submissions, DMC/CEC meetings, IRB packages, and scientific publications with statistical deliverables. + Summarize statistical… more
- Kerry (Beloit, KS)
- …+ Food Safety and Microbiology + Food Chemistry and Process Engineering + Regulatory Compliance and Packaging Science + Proven experience in flavor development ... taste and nutrition company for the food, beverage and pharmaceutical industries. Every day we partner with customers to...analysis of flavors + Employ thorough knowledge of relevant regulatory requirements for flavors + Work with cross functional… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- …* Report, publish, and present HEOR data and study results, ensuring compliance with regulatory standards and effectively communicating evidence to ... and apply insights to pipeline and marketed products, ensuring submissions meet regulatory and payer expectations for value demonstration and reimbursement.… more
- Gilead Sciences, Inc. (Foster City, CA)
- …deliverables. + Serve as an author and reviewer of CMC sections in regulatory filings, and support interactions with health agencies. + Collaborate across Gilead ... Pharmaceutical Development & Manufacturing (PDM) and partner with Quality,...(PDM) and partner with Quality, Supply Chain, Manufacturing, CMC Regulatory Affairs, Clinical Development and Technical Development to ensure… more
- Insight Global (New York, NY)
- …risk mitigation strategies and documentation. Experience engaging with security, cloud, and compliance teams to ensure all deliverables meet regulatory and ... Job Description One of our largest pharmaceutical customers is seeking a Product Manager Delivery...enablement and administration when necessary (ushering the project through compliance and SDLC). Familiarity with customer security group, cloud,… more