- Parexel (Hartford, CT)
- …Minimum 5 years of biotech/pharma industry experience, including 2+ years in labeling / regulatory operations with global responsibility. * Experience leading ... Join us as a **Global Labeling Operations Manager** , where you'll...* Strong knowledge of US, EU, DE, CH, AU regulatory labeling lifecycle management. * Experience with… more
- Sumitomo Pharma (Hartford, CT)
- …dynamic, highly motivated, and experienced leader for the position of **Vice President, Regulatory Affairs Oncology** . The candidate must be deeply experienced ... to VP Clin Dev and CMO + Manage Commercial Regulatory Affairs function and serve as an...claims and assess consistency of proposed claims with FDA-approved labeling + Provide regulatory leadership to the… more
- GRAIL (Hartford, CT)
- …products with the FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing submissions such as PMAs, 510(k)s, post-approval ... and review of Standard Operating Procedures and policy guidelines within the regulatory affairs department. + Perform other duties as assigned. **Required… more
- Oracle (Hartford, CT)
- …To remain competitive in this rapidly changing landscape, organizations require regulatory affairs professionals who can navigate complex and fast-changing ... the globe. In this context, we are looking for regulatory affairs experts in the med-tech space...expertise, healthcare and life science organizations can streamline their operations , gain insights from data, and make more informed… more
- Sumitomo Pharma (Hartford, CT)
- …highly motivated, and experienced individual for the position of **Associate Director, Regulatory Affairs (Oncology).** The Associate Director is part of the ... Global Regulatory Affairs (GRA) team based in the...prepares regulatory submissions and works closely with Regulatory Operations in the electronic submission +… more
- Boehringer Ingelheim (Ridgefield, CT)
- …with Corporate and local regulatory requirements. The AD, DRA Product Labeling Operations will provide training, advice, and mentoring to affected ... cross-functional colleagues and within Labeling Operations , as appropriate, for ...ten (8-10) years' experience in the pharmaceutical industry in Regulatory Affairs or scientific discipline required OR… more
- Otsuka America Pharmaceutical Inc. (Hartford, CT)
- …with members of the global regulatory team (GRL, regional leads, CMC-RA, labeling , medical writing, regulatory operations , etc.) to develop global ... years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical development, project management, quality… more
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