- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …advance scientific exchange and product innovation. + Offer clinical expertise for regulatory submissions and communicate with FDA and international authorities ... settings and laboratory diagnostics. + Demonstrated record of supporting successful product submissions to US/EU regulatory authorities. + Ability to interpret… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …and existing LSM products for the BU + Reviews all Clinical Study Reports and regulatory submissions to ensure adequacy of support for all claims pertaining to ... effectiveness, and clinical performance of all products. Provides clinical expertise in submissions and communication with FDA and other Regulatory authorities… more
- Cytel (Trenton, NJ)
- …the pre-specified timelines + Support the preparation of clinical study reports, regulatory submissions , publications, annual DSUR, and exploratory analyses + ... medical terminology, clinical trial methodologies, and FDA/ICH regulation + Experience supporting regulatory submissions , interacting with the FDA and/or global … more
- J&J Family of Companies (Raritan, NJ)
- …+ Direct and oversee the preparation, accuracy, messaging, and completeness of regulatory submissions that support business portfolio + With a focus ... **Job Function:** Discovery & Pre-Clinical/Clinical Development **Job Sub** **Function:** Regulatory Science **Job Category:** People Leader **All Job Posting… more
- Merck (Rahway, NJ)
- …, Operations, Non-clinical, Clinical, and other functional areas + Experience with regulatory submissions including writing / review of regulatory ... formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. These sterile products… more
- Merck (Rahway, NJ)
- …process validation, second generation process development and authoring of regulatory submissions . Under the general scientific and administrative ... (PPQ), risk assessment (RA), control strategy, process comparability reports, and/or regulatory submissions (BLA/MAA/JNDA etc.). + Adaptability and agility to… more
- Bristol Myers Squibb (Princeton, NJ)
- …on translational data generated to support asset development and contribute to regulatory submissions . This individual will work on cross-functional project ... written documents such as primary manuscripts/publications/reviews, scientific presentations and regulatory submissions (INDs/NDAs) with ability to synthesize… more
- J&J Family of Companies (Raritan, NJ)
- …include the generation and review of pharmacometric documents related to regulatory submissions , preparing responses to Agency questions and preparing ... stages (Phase 1-3). + Performing population PK/PD analyses in support of regulatory submissions . + Developing & reviewing study designs, writing analysis plans &… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …of statistical concepts, techniques and clinical trial principles) and good knowledge of regulatory submissions and requirements + Ability to work on global ... on complex programming tasks, standards, and processes + Support global regulatory authority submissions including preparing programming result for submission… more
- System One (Park Ridge, NJ)
- …+ Oversee microbiological method development, validation, and data interpretation for regulatory submissions + Manage complex laboratory investigations and ... technical direction, leading high-impact sterilization programs, and ensuring full regulatory compliance across the product lifecycle-from development through commercialization.… more
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