- Regeneron Pharmaceuticals (Troy, NY)
- … strategies for the assigned drug/device portfolio. This role involves overseeing regulatory affairs staff, various outside contractors, supporting project teams ... **A typical day might include:** + Oversee the assigned CMC/CP Regulatory Affairs team, driving global regulatory strategies and operational direction… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Senior Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory ... + Coordinate the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of product… more
- Bath & Body Works (New York, NY)
- …with the option to be located in NYC OR Columbus, OH* The International Regulatory Affairs Manager position will be responsible for developing and implementing ... compliance strategy for global market. This role, reporting to Principal, International Regulatory Affairs (Associate Vice President) is responsible for ensuring… more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- …with 5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical development, project management, ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
- Parexel (Albany, NY)
- …markets? Parexel is seeking an experienced and highly motivated **Global Regulatory Labeling Lead** to provide strategic leadership and operational oversight for ... This role is integral to the development, governance, and maintenance of regulatory labeling content that supports the safe and effective use of products… more
- Parexel (Albany, NY)
- …DE, AU) and non-US/Central EU markets, ensuring compliance with global regulatory requirements and supporting cross-functional teams in delivering accurate, timely, ... and social media compliance. * Ensure compliance with country-specific regulatory requirements. * Act as key partner to GRA...requirements. * Act as key partner to GRA Regions, Regulatory CMC and Supply Chain. Qualifications: * University degree… more
- Capgemini (New York, NY)
- …& Experience** **Skills & Experience (Required)** + **12+ years** in regulatory affairs ; direct leadership of **IND/NDA/BLA/MAA** submissions (10+ successful ... Capgemini Invent - LS Reg Affairs & Qlty - Sr Consultant At Capgemini...As a Senior Consultant, you'll act as a **trusted regulatory advisor** for pharma and biotech clients, leading engagements… more
- Pfizer (New York, NY)
- …**QUALIFICATIONS / SKILLS** + Bachelor's or Master's degree, preferably in Life Sciences, Regulatory Affairs , Data Management, or related field. + 8+ years of ... experience in Regulatory Affairs or Regulatory Operations, with at least 2 years in a data governance, data management, or data quality/compliance role. +… more
- Mount Sinai Health System (New York, NY)
- …science or legal/ regulatory studies + 3+ years of direct experience in Regulatory Affairs , Clinical Affairs or Quality Assurance within the Medical ... **Job Description** A Regulatory Compliance Coordinator position is currently available within...not limited to, management of clinical studies through the regulatory portion of the trial submission process, ensuring … more
- Regeneron Pharmaceuticals (Rensselaer, NY)
- …with 12 years of relevant biopharmaceutical experience, at least 8 years of hands-on regulatory affairs or regulatory intelligence experience. + Balance of ... The Senior Director of Regulatory Intelligence will lead global regulatory ...+ Liaise with Legal and Public Policy and Government Affairs (PP&GA), as necessary, to ensure consistency in interpretation… more
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