- 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 ... and 1 NDA) + Knowledge of and Compliance with FDA , EMEA, PMDA guidances + Performance will be monitored...draft submission packages. Performance metrics will include completion of regulatory submissions, adherence to timelines, and the quality… more
- Merck (Rahway, NJ)
- …product life cycle. + Oversee the preparation, submission, and follow-up of regulatory applications and ensure quality and compliance across all documentation. ... + Interact independently with regulatory agencies ( FDA , EMA, etc.), including leading meetings, teleconferences, and written communications. + Lead… more
- Integra LifeSciences (Princeton, NJ)
- …include performing data analysis, managing data uploads and verification, and ensuring high- quality , timely support for the Global Regulatory Affairs function ... to advance patient outcomes and set new standards of care. The regulatory operations specialist position provides support across multiple functional areas, including… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …documentation and product labeling in consideration of US, EU, and other global regulatory requirements. + Authors FDA submissions, EU technical files, and other ... product review and approval. + Point of contact for FDA , EU notified bodies, and other regulatory ...submissions. + Knowledge of product development and medical device quality system regulations. + Experience with product development processes… more
- Sanofi Group (Morristown, NJ)
- …on organizational structure. **About You** **COMPETENCES** + Strong knowledge of global regulatory labeling requirements ( FDA , EMA, ICH) and lifecycle labeling ... **Job Title:** Director, Global Regulatory Affairs - Global Labeling Strategy **Location** :...consideration of patient experience data (eg, Patient Report Outcomes, quality of life measures). This strategic input ensures alignment… more
- Merck (Rahway, NJ)
- …the identification, planning, execution, and management of activities that deliver high quality and timely regulatory and safety submissions for approval. The ... Director, Portfolio & Program Management (PPM)** The Associate Director in Regulatory Planning and Publishing works closely with various stakeholders to drive… more
- Integra LifeSciences (Plainsboro, NJ)
- …preferably in FDA regulated industry. + Experience with the application of FDA and/or ISO Quality System Requirements. + Evidence of a strong work ... patient outcomes and set new standards of care. The **Internal Auditor, Regulatory Compliance** will have an in-depth understanding and knowledge of appropriate GMP… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …relevant experience. + BA/BS with 10+ years' relevant experience. + Significant regulatory , quality , compliance or related experience in the biopharma industry. ... Other Requirements** + In-depth understanding of US Food & Drug Administration ( FDA ) and European Medicines Agency (EMA) regulatory requirements and… more
- Grifols Shared Services North America, Inc (Trenton, NJ)
- …more than 110 countries and regions. **Summary:** Develops and implements worldwide regulatory programs for marketed products and/or those for development, and has ... interactions with regulatory authorities to expedite approvals. Participate in the development...May have responsibility for maintaining a compliant medical device quality system for R&D and informing project teams of… more