- Teleflex (Wyomissing, PA)
- …partner with Product Management Regulatory Affairs personnel to support 510(k)s, Canada License applications, European Union (EU) Medical Device ... files and documentation to ensure continued compliance. - Support regulatory compliance activities, including Health Canada license renewals, Food and… more
- ITG Brands (Greensboro, NC)
- …and nicotine products. Serve as a strategic legal advisor on FDA regulatory matters, including product submissions, labeling, marketing, enforcement, and ... reporting. Lead legal strategy and support for regulatory litigation and administrative proceedings....Juris Doctor (JD) from an accredited law school. Active license to practice law in at least one US… more
- Revelyst (San Diego, CA)
- … changes required to remain in compliance with global laws and regulations. + Support product compliance team and legal submission of global mandatory reports to ... Experience with product compliance and safety considerations + Understanding of regulatory framework, with strong experience with regulatory issues as it… more
- WCG Clinical (Cary, NC)
- Data Analytics & Insights (DAI) Product Solutions, Associate Director (Remote) **General Information** **Location:** Cary, NC, Remote **Organization:** ... experience, skills, education, and geographic location. **JOB SUMMARY:** The DAI Product Solutions Associate Director is a key leader responsible for advancing… more
- WCG Clinical (Raleigh, NC)
- …clinical operations, and/or multiple clinical software systems (eg for clinical site support , patient engagement, safety, regulatory review, etc,). + Commercial ... Senior Director, Product Management & Strategy (Remote) **General Information** **Location:** Cary, NC, Remote **Organization:** WCG **Job Type:** Full Time -… more
- Merck & Co. (Rahway, NJ)
- …and inline products from early design concept definition through commercialization to support regulatory filing, product launch, and post-market ... of product development and design control principles to positively support and influence clinical and commercial combination product development and… more
- Merck & Co. (Rahway, NJ)
- …guidance in support of small molecule drug substance and drug product container closure systems including mold qualification and regulatory compliance.- To ... on driving continuous improvement and implementing best practices in technical support and product stewardship.Excellent communication and interpersonal skills,… more
- Merck & Co. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... lead in project teams.Lead, develops, coordinates, and provides biostatistical support for related drug/vaccine projects in Late Development Statistics.Lead the… more
- Merck & Co. (Rahway, NJ)
- …and validation; and design control and risk management techniques to positively support and influence clinical and commercial combination product development and ... submissions (INDs, IMPDs, NDAs, BLAs, etc.) for combination product programs under your leadership.Lead/ support /oversee clinical supplies production… more
- Formation Bio (New York, NY)
- …with other CMC groups (analytical development, supply chain, etc) quality assurance, regulatory , clinical pharmacology and project management to support short ... regulatory submissions, including INDs, BLAs, and other regulatory dossiers. Due-Diligence Support : As part of...Support : As part of Formation Bio's strategy to in- license programs and develop to point of inflection, … more
- Merck & Co. (Rahway, NJ)
- …and Technology, will be responsible and accountable for subject matter expert technical support for distribution and logistics of human health Drug Substance, Drug ... Product and Finished Goods globally.- The Packaging Technical Operations...responsible providing Logistics and Distribution Technology Center of Excellence support to the enterprise.- The leader will be responsible… more
- Bayer (Whippany, NJ)
- …development of an endorsed Clinical Development Plan in line with the Target Product Profile, designed for successful regulatory approval and market access for ... partners; Support registration, market access, commercialization, and maintenance of product licenses (eg, Core Data Sheet, Periodic Safety Update Report,… more
- Merck & Co. (Rahway, NJ)
- …Technology will be responsible and accountable for subject matter expert technical support for distribution and logistics of human health Drug Substance, Drug ... Product and Finished Goods globally.-The Packaging Technical Operations organization...responsible providing Logistics and Distribution Technology Center of Excellence support to the enterprise.- The leader will be responsible… more
- Syner-G BioPharma Group (Boston, MA)
- …and maintain SOPs, maintenance logs, and documentation for inspections and audits. Support regulatory inspections and ensure compliance with OSHA, EPA, ... industry, supporting critical phases of the drug development lifecycle, from discovery and regulatory approval to technology transfer and the support in capital… more
- Novo Nordisk Inc. (Seattle, WA)
- … strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...external customers to further scientific exchange. S/he provides advanced product and scientific and medical field support … more
- Novo Nordisk Inc. (New Orleans, LA)
- … strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...external customers to further scientific exchange. S/he provides advanced product and scientific and medical field support … more
- Merck & Co. (Rahway, NJ)
- …team, responsible for spearheading risk management efforts in combination product development, commercialization, and lifecycle management. This individual will ... extensive collaboration with subject-matter experts across various cross-functional combination product development teams throughout all phases of the product… more
- Merck & Co. (Durham, NC)
- … product dispositionPreparing and/or providing guidance and review for regulatory filings, process descriptions, investigations, and change requests. Acts as a ... Operations, Process Automations, Process Engineering, Process Optimization, Process Simulation, Product Formulation, Quality Assurance Processes, Quality Operations, Regulatory… more
- Merck & Co. (Durham, NC)
- …control, deepening process understandingAuthor, review, and/or edit technical documents to support regulatory filings including technical reports and risk ... vaccine capital projectsProvide deep SME knowledge for manufacturing investigations support ( Product and process deviations and complex… more
- Merck & Co. (Durham, NC)
- …documents, and industry standards Lead company and site preparation activities for support of regulatory and customer inspections Provide compliance advice to ... the site.- - Position Responsibilities: Actively manage, mentor, and support site auditors to ensure performance of auditors contributes...site, development and commercial product teams Supports and continually enhance the ongoing site… more
