- Sumitomo Pharma (St. Paul, MN)
- …highly motivated, and experienced individual for the position of Associate Director Regulatory Affairs. The Associate Director is part of the Global Regulatory ... (GRA) team based in the US. He/she will primarily function as the Regional Regulatory Leader (RRL) and/or Global Regulatory Leader (GRL) for assigned projects.… more
- Otsuka America Pharmaceutical Inc. (St. Paul, MN)
- …Review overall quality of ad hoc query research for requested regulatory topics and confirm acceptability of responses. + Demonstrate understanding of the major ... affairs experience. + Minimum 2-3 years' work experience in regulatory intelligence. + Previous interactions with FDA ...in regulatory intelligence. + Previous interactions with FDA or other health authority are desirable. **Skills and… more
- Schwan's Company (Marshall, MN)
- …brand CJ CheilJedang Corporation, is a leader in manufacturing and marketing quality foods enjoyed nationwide. We have beloved brands like Red Baron(R), Tony's(R), ... a job, it's a seat at the table! The Regulatory Affairs Specialist, based out of Bloomington, MN or...for developing and maintaining product labeling that complies with FDA , FSIS, FNS, and international regulations. This role provides… more
- Abbott (Plymouth, MN)
- … regulatory requirements. Complies with US Food and Drug Administration ( FDA ) regulations, regulations and other regulatory requirements, company policies, ... a fast-paced, changing environment. + Experience working inmedicaldevice industry withfocuseson regulatory , or quality systems preferred. + Experience working… more
- Parexel (St. Paul, MN)
- …Regulatory Affairs, Tech Ops, etc. for labeling distribution, tracking and quality control. + Utilize regulatory /product knowledge to provide operational ... experience + Extensive years of experience in an industry-related environment; experience with a regulatory agency (such as FDA , MHRA) is a plus **Education:** +… more
- Parexel (St. Paul, MN)
- …and evaluating clinical sections of regulatory applications. + Previous experience with a regulatory agency (such as the FDA or MHRA) as a Senior / Master ... shape it. As a **Senior/Vice President, Technical** on our Regulatory Strategy (RS) team, you'll be at the forefront...activities as well as facilitate business decisions + Produces quality work that meets the expectations of RS and… more
- Sumitomo Pharma (St. Paul, MN)
- …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 US. He/She...provides possible solutions and mitigation strategy + Ensures the quality and content of all submissions to Health Authorities… more
- Parexel (St. Paul, MN)
- …Consultant level role, 7+ years for a Senior Consultant * Proven success in preparing regulatory documentation for FDA , EMA, and Health Canada (IND, NDA, DMF) * ... opportunity for an experienced and highly motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs Senior/Consultant. This… more
- Avera (Minneapolis, MN)
- …required research documents to the protocol sponsor, the Institutional Review Boards (IRB), the FDA , and any other regulatory agency as required by the research ... **Required Education, License/Certification, or Work Experience:** + 2 years regulatory , quality or data analyst **Preferred Education, License/Certification,… more
- Merck (Worthington, MN)
- …Readiness, Drug Product Manufacturing, FDA Compliance, FDA GMP, FDA Inspections, FDA Regulatory Requirements, Inspection Readiness, Pharmaceutical ... a combination of experience. + Minimum of 10 years of manufacturing, technology, and/or quality experience within an FDA , USDA, and/or EU API, Drug Product,… more