- Merck & Co. (Rahway, NJ)
- …Research Laboratories (Research & Development) by:Developing an active engagement strategy with US FDA and global health authorities to advocate advanced ... the continuous improvement of the operating model for regulatory activities in the US and globally to execute efficiently on regulatory obligations, compliance … more
- 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …teams, manage performance, and develop talent. Ability to create an engaged workforce.GMP Compliance & Regulatory Knowledge: Deep understanding of FDA , EMA, and ... and release of product to patients.Serve as the delegate for the Head of Operations.Establish key stakeholder relationships with internal and external stakeholders.… 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
- Merck (Rahway, NJ)
- …Laboratories (Research & Development) by: + Developing an active engagement strategy with US FDA and global health authorities to advocate advanced regulatory ... the continuous improvement of the operating model for regulatory activities in the US and globally to execute efficiently on regulatory obligations, compliance … more
- Pfizer (New York, NY)
- …compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or ... member of the SSRM-LT. They may represent SSRM Unit Head in WWS management and operational matters, and may...any location outside of the United States . Relocation assistance may be available… 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
- Gilead Sciences, Inc. (Parsippany, NJ)
- …to the terms and conditions of the applicable plans. **For jobs in the United States :** Gilead Sciences Inc. is committed to providing equal employment ... strong leaders that are committed to giving each of us a voice while achieving our mission. Our collaborative...assigned R&D groups / locations to ensure ongoing regulatory compliance , R&D quality and fit-for-purpose to both Gilead business… 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
- embecta (Parsippany, NJ)
- …promotion globally. This role reports to the Sr. Director, North America Commercial and Head of Global Ethics, Compliance and Privacy and will work closely with ... Facebook , Instagram and X (http://twitter.com/embecta) . **Why join us ?** A career at embecta means being part of...data breach notification laws, and marketing and promotion standards ( FDA , FTC and similar), ensuring compliance and… more
