- AbbVie (Waltham, MA)
- …years regulatory experience. Some portion may include experience related to pharmaceutical regulatory work (eg, other R&D role or specialized training). ... global regulatory strategies. + Preferred Experience: 10+ years' experience in pharmaceutical regulatory activities, with experience as lead regulatory … more
- Takeda Pharmaceuticals (Boston, MA)
- …bring life-changing therapies to patients worldwide. Join Takeda as Director, Global Regulatory Labeling Strategy where you will be responsible for the development ... CCDS, USPI and EU SmPC enabling the most up-to-date information and in compliance with labeling requirements to be provided to patients and Health Care Providers… more
- Takeda Pharmaceuticals (Boston, MA)
- …the global regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversees direct reports or junior staff responsible. + ... timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements. **How you will contribute:**… more
- Takeda Pharmaceuticals (Boston, MA)
- …ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance ; Assist the Global Regulatory Lead with Health ... opportunity: **JOB LOCATION:** Cambridge, MA **POSITION** : Manager, Global Regulatory Affairs, Marketed Products **POSITION DESCRIPTION** : Takeda Development… more
- Takeda Pharmaceuticals (Boston, MA)
- …the global regulatory strategy is updated and executed, ensuring global regulatory compliance . + Ensures global regulatory strategies defined within ... to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements. + Is a leader both in… more
- Takeda Pharmaceuticals (Boston, MA)
- …the global regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversees direct reports or junior staff responsible. + ... maintain compliance for products. + Oversee vendor responsibility for regulatory activities and submissions related to projects within scope. + Participates with… more
- Dana-Farber Cancer Institute (Boston, MA)
- …submits regulatory documents, and maintains records on assigned studies to ensure regulatory compliance with DFCI and DF/HCC policies as well as federal ... work with amazing partners, including other Harvard Medical School-affiliated hospitals. ** Regulatory Compliance ** + Prepares and submits all protocol… more
- Rhythm Pharmaceuticals (Boston, MA)
- …team, you'll be responsible for the effective management and timely execution of regulatory filings, maintaining compliance with global regulatory standards ... timelines + Ensure effective and timely execution of regulatory filings in compliance with relevant ...in drug development and product registration activities within the pharmaceutical or biotech industry in multiple phases of development… more
- Sanofi Group (Cambridge, MA)
- …documents (such as IB, PBRER, DSUR, RMP, etc.). + Support operational and compliance activities for assigned regulatory deliverables and develop regulatory ... **Job Title:** Regulatory Strategist- Innovation Franchise **Location:** Cambridge, MA, Morristown,...related field with at least 5 years of relevant pharmaceutical /biotechnology industry experience, including at least 3 years of… more
- Bristol Myers Squibb (Cambridge, MA)
- …. **Position Responsibilities** + Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion ... digital health and other devices to enhance the value of our pharmaceutical products across therapeutic areas + Responsible for understanding the regulatory… more
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