- Mount Sinai Health System (New York, NY)
- …cancer clinical trials for the division. Duties include, but are not limited to, management of clinical studies through the regulatory portion of the trial ... efficient, compliant, and scientifically sound manner. The CCTO is composed of regulatory , financial, clinical, study management , compliance, and data … more
- TECO Energy (Tampa, FL)
- …to federal and state regulatory agencies. This role maintains the Regulatory Affairs case management system website and utilizes FERC-mandated and ... Regulatory Affairs Utility Industry Natural Gas FERC Compliance FPSC Tariff Management Rate Case Support Regulatory Filings Utility Operations Legal… more
- Strata-G, LLC (Oak Ridge, TN)
- …Lead will supervise a team direct report and matrixed staff in regulatory strategy, safety basis documentation, requirements management , probabilistic risk ... values to create a culture of significant and positive change for our clients and the world. We Care...successes with the community. Strata-G is seeking an experienced Regulatory Affairs Lead with the following: Summary: The … more
- Olympus Corporation of the Americas (Westborough, MA)
- …with the ability to coordinate cross-functional teams and manage multiple regulatory projects/initiatives. + A digital-native, change -embracing mindset, with a ... This role is a digital-native leader responsible for shaping, coordinating, and managing regulatory activities across the Digital Unit (DU). The DU is a high-growth,… more
- Takeda Pharmaceuticals (Boston, MA)
- … developments, and utilize experience to oversee the strategic assessment of external regulatory changes on internal pipeline. Drive change , as needed. + ... pipeline development and build external advocacy strategy to target significant change . + External Trade Association Management and Assessment: Coordinate… more
- Lilly (Philadelphia, PA)
- …including authoring, review, and finalization + Lead and contribute to responses to regulatory agency questions globally + Review change controls to assess ... to those who need them, improve the understanding and management of disease, and give back to our communities...the world. **Position Overview:** The Associate Director - CMC Regulatory will leverage CMC technical knowledge and regulatory… more
- GRAIL (Concord, NH)
- …provide direction to regulatory staff and, when required, participate in senior management meetings as a delegate. The role fosters a work culture aligned with ... when it can be cured. We are working to change the trajectory of cancer mortality and bring stakeholders...**Experience** + Minimum of 10 years of experience in regulatory , development, clinical affairs, quality, or program management… more
- Actalent (Irvine, CA)
- …EU MDR knowledge. + QMS awareness/knowledge. + Experience with post-market and change management . + RAC Certification (preferred). Additional Skills & ... Job Title: Regulatory Affairs Specialist II Job Description A ...Familiarity with FDA and EU MDR. + Strong project management , analytical, and communication skills. + Ability to work… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription ... activities for all assigned projects in alignment with the Global Regulatory Lead. Translates complex pertinent global requirements and provides an assessment… more
- Otsuka America Pharmaceutical Inc. (Baton Rouge, LA)
- …annual budget, and manage spend. + Author and conduct periodic review of regulatory intelligence management Standard Operating Procedures or work practices. + ... The Associate Director of Regulatory Intelligence leads the collection and dissemination of...and supporting senior leadership. + Previous experience with people management and team leadership. + Excellent interpersonal and communication… more