- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and company strategy. Act as management representative for all key health authority inspections ( US FDA , EU EMA, MHRA etc.,). Develop and maintain an effective ... working relationship with US FDA and other international bodies.Ensure adequate...functions. Identify appropriate continuous improvement initiatives for quality and compliance related areas.May Deputize for the Head ,… more
- Merck & Co. (Rahway, NJ)
- …BDSC supports stage 1 & 2 process validation deliverables (2011 FDA process validation guidance) including various pipeline commercialization activities, process ... of regulatory submissions.-Under the general scientific and administrative direction of the Head of Biologics Cell Culture Sciences and working in conjunction with… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Compliance Head - US FDA **Location** : Framingham, MA, Morristown, NJ **Job Title:** Compliance Head - US FDA **Location** ... thought was possible. Ready to get started? **Main Responsibilities:** . **Ensure US FDA GMP Inspection Readiness, Inspection Activities, Inspection Follow-Up**… more
- Bayer (NJ)
- …YOU ARE** Bayer seeks an incumbent who possesses the following: **Required Qualifications:** + US FDA regulatory experience in related drug or device area; + ... US commercial and global R&D objectives and in compliance with all regulatory and legal obligations. This position...contact information below. Bayer is an E-Verify Employer. **Location:** United States : New Jersey : Whippany… more
- BeOne Medicines (Pennington, NJ)
- …as needed. + Support all QA shop floor and batch systems to ensure compliance with FDA /EU regulations, covering cGMP for commercial medicinal products and ... closure dates, and QA objectives, whilst adhering to regulatory compliance and achieving business success. Work to support both...business, which may be requested by the QA Department Head , for which training and/or an explanation has been… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …company strategy. + Act as management representative for all key health authority inspections ( US FDA , EU EMA, MHRA etc.,). Develop and maintain an effective ... working relationship with US FDA and other international bodies. + Ensure adequate CAPAs are defined, implemented, and closed through providing guidance and… more
- Sanofi Group (Morristown, NJ)
- …and Regulatory Inspections. + Covers an international scope including major regulators; US FDA (USA), EMA (Europe), ANSM (France), National Medical Products ... + Direct experience preparing for and supporting Regulatory Inspections from Regulators (eg, US FDA , ANSM, PMDA, NMPA, EMA, MHRA, etc.) + Action oriented,… more
- Organon & Co. (Jersey City, NJ)
- …are position specific. Please, no phone calls or emails. **Applicable to United States Positions Only:** Under various US state laws, Organon is required to ... The Global Medical Strategy Lead will report to the Head , Medical Affairs and Outcomes Research (MAOR). The role...across therapeutic franchises, and will work closely with the US Medical Affairs Lead, Global Medical Affairs Lead and… more
- Sanofi Group (Morristown, NJ)
- … Established Products (EP) Publication Lead position, reporting directly to the Head , US General Medicines Scientific Communications and Medical Operations, will ... include but is not limited to documents prepared by FDA , OIG, DDMAC/OPDP, PhRMA, ICMJE, ACCME, etc. + Ensure...operating within all policies, procedures, and guidance to ensure compliance with SOPs and US CIA requirements,… more
- Merck (Rahway, NJ)
- …BDSC supports stage 1 & 2 process validation deliverables (2011 FDA process validation guidance) including various pipeline commercialization activities, process ... Under the general scientific and administrative direction of the Head of Biologics Cell Culture Sciences and working in...PPQs and BLAs for the company's pipeline. + Champion compliance and safety; promote a culture of diversity, inclusion,… more
