- Takeda Pharmaceuticals (Boston, MA)
- …and efficient development and maintenance of plasma derived therapies, while ensuring compliance with applicable regulatory requirements. + Serves as the primary ... patients with immunologic, hematologic, and other complex diseases. The Regulatory Lead is accountable for recommending and implementing ...plus. BA accepted + Minimum of 10 years of pharmaceutical industry experience, with a minimum of 8 years… more
- Fresenius Medical Center (Waltham, MA)
- …AND SCOPE:** Assists in the support of the daily operational activities within Regulatory Affairs for the preparation of regulatory submissions required to ... international markets as assigned. Maintains systems designed to ensure compliance with electronic submission requirements and document management systems.… more
- Bausch + Lomb (Boston, MA)
- …global reporting, administrative documentation, due diligence, market expansion, labeling content, regulatory compliance , regulatory intelligence and change ... closely with commercial leaders to define strategy and execute registrations, provides regulatory intelligence and ensures regulatory compliance . + Provide… more
- Chiesi (Boston, MA)
- …+ Knowledge of medical, pharmaceutical , or healthcare processes, including regulatory requirements and compliance standards + Proven ability to develop, ... care and consumer-facing self-care). We are proud to be the largest global pharmaceutical group to be awarded B Corp Certification, a recognition of high social… more
- Dana-Farber Cancer Institute (Boston, MA)
- …or OnCore policies and pharmaceutical company as outlined in protocol. ** REGULATORY & COMPLIANCE :** + Assumes responsibility for essential document ... tracking and complying with clinical trial performance benchmarks; eg protocol and regulatory compliance , patient safety, staff development & training and… more
- Sanofi Group (Framingham, MA)
- …tracked and mitigated + Ensuring the company is always prepared for inspections by regulatory bodies for topics related to dossier compliance + Ensure that any ... + Demonstrated problem solving skills. + Extensive experience in ensuring compliance with local, national, and international pharmaceutical regulations and… more
- ThermoFisher Scientific (Waltham, MA)
- …products and make Quality a competitive advantage by achieving an extraordinary GMP regulatory compliance with zero patient impacting events and drive quality ... closed loop program for the effective implementation of major regulatory changes. * Ensures compliance to all... regulatory authorities from an auditing perspective with regulatory experience in a pharmaceutical GMP environment… more
- Sumitomo Pharma (Boston, MA)
- …+ Minimum 2 - 3 years of relevant experience in biotech or pharmaceutical industry specific to Pharmacovigilance operations and compliance . + Strong ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations...considered confidential. ** Compliance ** : Achieve and maintain Compliance with all applicable regulatory , legal and… more
- Chiesi (Boston, MA)
- …knowledge of medical, pharmaceutical , or healthcare processes, including regulatory requirements and compliance standards + Interpersonal and Leadership ... self-care). We are proud to be the largest global pharmaceutical group to be awarded B Corp Certification, a...ensuring timely delivery of impactful outcomes while adhering to compliance and governance standards + Develop and maintain systems… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …materials or other types of product communications to provide comprehensive regulatory compliance guidance. + Ensures product promotional materials are ... (life sciences disciplines strongly preferred) + 4+ years of experience in promotional compliance and product labeling in the pharmaceutical industry + Advanced… more