- Medtronic (Boston, MA)
- …in a more connected, compassionate world. **A Day in the Life** Job Summary: Principal Regulatory Affairs Specialist As a Principal Regulatory Affairs ... Specialist, you will play a key role in ensuring regulatory compliance and supporting the global market expansion of products commercialized by Digital Technologies.… more
- Merck (Boston, MA)
- …+ Coordinate regional regulatory strategy and submissions through collaboration with Regulatory Affairs Europe (RAE) and local affiliate teams. + Provide ... + Local registration study protocols for secondary markets + Represent Global Regulatory Affairs on internal committees (eg, DRC, ADT/PDT, EDT, LEAD) to provide… more
- Takeda Pharmaceuticals (Boston, MA)
- …Global Regulatory Project Management and Strategic Planning within our Global Regulatory Affairs organization, based remotely. + Partners with the Global ... changes through proactive engagements with cross functional team members, Global Regulatory Affairs TAU colleagues and Global Regulatory Project Management… more
- Pfizer (Cambridge, MA)
- …Requirements)** + BS is required. MS, PharmD, or PhD preferred + Prior clinical regulatory affairs experience in vaccines is required, at least 8 years. + ... to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned. Regulatory Affairs more
- Grifols Shared Services North America, Inc (Worcester, MA)
- …8 or more years of experience in positions of increasing responsibility within Regulatory Affairs or related field within the Biologics, Biotech or ... Hiring Ordinance.** Learn more about Grifols (https://www.grifols.com/en/what-we-do) **Req ID:** 527460 **Type:** Regular Full-Time **Job Category:** Regulatory Affairs… more
- Sumitomo Pharma (Boston, MA)
- … Regulatory Advertising & Promotion** . The Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily function as ... the Regulatory reviewer for assigned products. This position is responsible...eg Marketing and their Agencies, Legal, Compliance, and Medical Affairs . + Provide appropriate oversight of promotional material review… more
- Actalent (Boston, MA)
- …PharmD, or PhD preferred. + Minimum of 8+ years of experience in CMC Regulatory Affairs for biologics, including IND activity, global CTAs, DSURs, and agency ... Job Title: Director Regulatory CMC Job Description We are seeking a creative and agile regulatory professional eager to join a collaborative team as a… more
- Beth Israel Lahey Health (Boston, MA)
- …+ Bachelor's degree in Life Science or related field required; Master's degree in Regulatory Affairs preferred. + Minimum of 3-5 years related work experience ... taking a job, you're making a difference in people's lives.** The Sr. Regulatory Specialist supports regulatory compliance for clinical research at Beth Israel… more
- Fresenius Medical Center (Waltham, MA)
- …reports on audit findings and corrective and preventive action recommendations to Regulatory Affairs , Quality as well as operations management and corporate ... **PURPOSE AND SCOPE:** Leads regulatory surveys and promotes utilization of continuous quality improvement (CQI) principles, methods, and tools. Directs,… more
- Rhythm Pharmaceuticals (Boston, MA)
- …or related field + 8+ years of highly relevant pharmaceutical/biotechnology experience in Regulatory Affairs Operations + Knowledge and understanding of the drug ... to overcome barriers, together. Opportunity Overview The Associate Director (AD) of Regulatory Operations is responsible for assisting the Head of Regulatory … more