- Amneal Pharmaceuticals (Piscataway, NJ)
- …and company goals and objectives. Essential Functions: + Develop and Execute Global Regulatory Strategies: Formulate and lead global CMC and clinical regulatory ... strategies for Biologics, Biosimilars, and Small Molecules.Ensure alignment with regulatory trends, innovation, and compliance while balancing business benefits and… more
- Canon USA & Affiliates (Trenton, NJ)
- ** Regulatory Affairs Specialist - Post Market - req1434** **OVERVIEW** Reporting to the Director Regulatory Affairs, the Regulatory Affairs Specialist is ... handling, coordination of product recalls, FMI processes, processing electronic submissions and state registrations. **RESPONSIBILITIES** + Remote position, **west… more
- BeOne Medicines (Pennington, NJ)
- …complex production related issues. + Familiarity with EMA and FDA regulatory requirements for process development submissions . **Other Qualifications:** + ... production operations at various scales. + Familiarity with EMA and FDA regulatory requirements for process development submissions . **Travel:** + Some travel… more
- System One (Florham Park, NJ)
- Job Title: Manager, Regulatory Operations Documentation Specialist - Contractor Location: Florham Park, New Jersey - hybrid 50% Type: Contract Compensation: $65 - ... $85 hourly Overview This role will lead the Regulatory Operations - Documentation Specialist team in overseeing the documentation processes within an organization,… more
- Actalent (Basking Ridge, NJ)
- Job Title: QA Regulatory Affairs Specialist Job Description This position requires reviewing label content to ensure accuracy, consistency, and compliance. The role ... related to labeling updates. + Coordinate labeling projects to ensure regulatory compliance. + Facilitate project completion through effective and detailed project… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …The Manager, Field Alert & Recall Compliance is responsible for overseeing regulatory activities related to Field Alert Reports (FARs), product recalls, and market ... be the contact person for the FDA and other regulatory agencies in regard to Field Alerts responses and...the dissemination of RAPID Alert escalations for Field Alert submissions . + Prepares and maintains FAR status report to… more
- Sumitomo Pharma (Trenton, NJ)
- …teams. Regulatory Interactions: + Prepare and present clinical data to regulatory agencies (FDA, EMA) during IND submissions , clinical study reports, and ... programs, and liaises with Clinical (including Clinical Operations), Biometrics, Regulatory , Early Clinical Development, Pre-clinical research, Medical Affairs and… more
- Sanofi Group (Bridgewater, NJ)
- …+ Broad experience in clinical development or post-marketing activities such a submissions , interactions with regulatory agencies or other external stakeholders ... for safety analysis, including quality, relevance to external stakeholders (eg regulatory authorities, medical journals), and scientific validity. + Accountable for… more
- Lilly (Branchburg, NJ)
- …non-sterile drug substance (API) manufacturing. + Engage in providing support during regulatory interactions such as RtQ of submissions , and on-site inspections ... external to Lilly, to ensure strategies are in-line with technical, quality and regulatory guidance, current expectations and business needs. This role also aids and… more
- ARUNDEL MACHINE (Emerson, NJ)
- …as needed + Ensure the company's products comply with all FDA regulations, prepare submissions and maintain regulatory databases + Adhere strictly to all CGMP, ... FDA 21 CFR820, ISO 13485, EU MDR and company procedures to ensure the quality and integrity of the products and safety of the workplace + Keep Quality area organized and clean + Keep stock of Quality materials such as tip protectors, test materials, etc. +… more