- Pfizer (Trenton, NJ)
- …Injectables experience, including buy-and-bill strategies and demonstrated knowledge of: Regulatory pathways ( FDA , EMA, Health Canada) and interchangeability ... public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses… more
- Cytel (Trenton, NJ)
- …comfortable interfacing with **senior executives** . + Experience interacting with ** regulatory agencies ( FDA /EMA)** and **key opinion leaders (KOLs)** . ... collaborating with a team of consultants and analysts to define optimal ** regulatory , clinical, and/or market access pathways** . + Develop **innovative solutions**… more
- Glenmark Pharmaceuticals Inc., USA (Elmwood Park, NJ)
- Associate Director, Regulatory Affairs Department: Regulatory Affairs Location: Elmwood Park, NJ START YOUR APPLICATION ... communication to support both internal and external customers (globally) including the US FDA . Job Responsibilities Note: These statements are not intended to be an… more
- Regeneron Pharmaceuticals (Warren, NJ)
- …incidents. + Ensure compliance with relevant regulations and standards, including GxP, FDA and other global regulatory requirements. + Maintain robust security ... measures to protect IT/OT infrastructure, including data integrity and disaster recovery planning. + Manage Cloud DevOps teams by tracking performance, addressing incidents, and ensuring disaster recovery plans are in place and functional. + Collaborate with… more
- Deloitte (Morristown, NJ)
- …support. + Regulatory Compliance: Ensure all solutions and processes meet global regulatory requirements (eg, FDA , EMA, PMDA) and industry best practices. + ... You will lead and deliver complex projects that drive innovation, regulatory compliance, and operational excellence for pharmaceutical, biotech, and medical device… more
- Robert Half Technology (Madison, NJ)
- …and incident response. + Track remediation efforts for audits, penetration tests, and regulatory findings (eg, FDA , SOX, GDPR). + Develop dashboards and ... This role will lead complex, cross-functional programs aligned to regulatory compliance, security modernization, risk remediation, data protection, and IT… more
- Oracle (Trenton, NJ)
- **Job Description** This role is dedicated to understanding healthcare regulatory requirements (such as HIPAA, HITRUST, FDA , etc.) and guiding cross-functional ... functions. Excellent communication, documentation, and executive presentation skills. Familiarity with regulatory frameworks (eg, HIPAA, HITRUST, FDA ) and their… more
- Stryker (Mahwah, NJ)
- **Senior Manager, Regulatory Affairs - Joint Replacement Division** **Location:** Hybrid - Mahwah, NJ As the **Senior Manager, Regulatory Affairs** , you will ... provide leadership and coordination of the Joint Replacement divisions' global regulatory strategies, submission preparation and approvals for new product launches… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription ... activities for all assigned projects in alignment with the Global Regulatory Lead. Translates complex pertinent global requirements and provides an assessment… more
- System One (Florham Park, NJ)
- …effectively in a cross-functional team environment. + Strong knowledge of regional regulatory requirements and guidelines, including FDA regulations and ICH ... Job Title: AD or Director, Regulatory Affairs Strategy Location: Florham Park, NJ (10...and 1 NDA) + Knowledge of and Compliance with FDA , EMEA, PMDA guidances + Performance will be monitored… more