- Bristol Myers Squibb (Princeton, NJ)
- …+ Provide regulatory support on product partnership, vendor management and business development opportunities + Serve as a strategic regulatory thought ... every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this...Jersey **Position Summary** The Director of Early Precision Medicine Regulatory Affairs leads global regulatory strategy for… more
- Regions Bank (Birmingham, AL)
- …logging into the careers section of the system. **Job Description:** At Regions, the Business Unit Compliance Analyst is a first line of defense risk management ... of the specific product or process within a specific line of business . Focus is on execution...regulatory agencies + Assists with the development of business group policies and procedures This position is exempt… more
- Truist (Charlotte, NC)
- …maintained by Regulatory Reporting Governance teammates in accordance with business or second line procedures. **Required Qualifications:** The requirements ... of the Truist regulatory reporting risk frameworks in alignment with second line of defense risk programs. Indirectly lead and collaborate with a team of… more
- Takeda Pharmaceuticals (Cambridge, MA)
- … Advisor and function as the "R" in the core Medical, Legal, and Regulatory review functions within the Commercial Material Review Process (CMRP). ... to bring life-changing therapies to patients worldwide. The Associate Director, Global Regulatory Affairs Advertising and Promotion (GRA A&P) Review Lead is… more
- Takeda Pharmaceuticals (Boston, MA)
- …create, revise and/or update product labeling (ie CCDS, USPI and EU SmPC) for regulatory submissions. + Ability to review product labeling for regulatory ... while driving to designated timelines for the execution of submission plans, regulatory requirements and business objectives. + Demonstrates a strong strategic… more
- Sumitomo Pharma (Little Rock, AR)
- … regulatory affairs activities; provide relevant input to Leadership + Oversee the regulatory activities at CROs, providing document review in order to ensure ... in compliance with FDA regulations and Company policies + Serve as the regulatory member of the scientific Medical Review Committee (sMRC) to ensure… more
- Boehringer Ingelheim (Ridgefield, CT)
- …pathways. This role will collaborate closely with US stakeholders to align US regulatory strategies with the overall business objectives. The Director, US ... US regulatory excellence and drive alignment between regulatory strategies and overall project and business ...on the overall project timelines. + Presents or supports review of US-specific regulatory topics to … more
- Boehringer Ingelheim (Ridgefield, CT)
- …approval requirements (eg, Variations database for US requirements). + sNDA Submissions: Review , and approve regulatory documents for submission, construct in ... Communications, clinical operations, translational medicine and clinical pharmacology, and regulatory affairs. This position will require the Fellow to develop… more
- Fifth Third Bank, NA (Cincinnati, OH)
- …experience to meet reporting standards. Provide guidance throughout the Bancorp as regulatory matters are applied to the various business activities. Responsible ... the regulatory agencies for accurate completion of regulatory reports. + Review completed reports for...compensation plan, with any such payment based upon company, line of business and/or individual performance. Our… more
- Sumitomo Pharma (Providence, RI)
- …expert on all regulatory matters with key external stakeholders, internal steering/ review committees, business partners, and government entities on a global ... regulatory strategies are aligned to the SMP group business strategy + Collaborate with Head of RA at...Responsible for providing global guidance and monitoring of global regulatory line items in the clinical development… more