- Merck & Co. (Upper Gwynedd, PA)
- … regulatory issues to GRACS CMC management, as neededDemonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the ... related pharmaceutical operations (eg, manufacturing, formulation and process development, analytical, quality assurance , n ovel modality and technologies such… more
- Katalyst HealthCares and Life Sciences (Magna, UT)
- …accuracy; and support other regulatory compliance activities, as needed Collaborates with Regulatory Affairs , Quality Assurance , and other associates ... ensure ongoing compliance This position is part of the Regulatory Affairs Compliance team, responsible to ensure...to Regulatory Affairs team Provides regulatory support for internal and external quality … more
- Kyowa Kirin North America (Princeton, NJ)
- …Experience 7+ years of pharmaceutical experience. Broad understanding of pharmaceutical development, Regulatory Affairs , Quality Assurance , Safety and ... California, North Carolina, and Mississauga, Ontario. Summary: The Project Manager, Global Regulatory Affairs Compliance and Planning will lead or support… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. JOB SUMMARYThe Senior Director, Head Medical affairs Quality Assurance in Global RD/PV QA is accountable ... SM) and relevant external stakeholders. The role will manage and or support medical affairs Quality resources (US, Brazil, Japan/ APAC and EU):in an efficient… more
- Pernod Ricard (Louisville, KY)
- …Nutrition, or related science degree. 3-5 years' experience in Alcohol or CPG company in Regulatory Affairs / Quality Assurance with a focus on TTB, FDA ... regulatory teams, legal, Brand Companies, and global Innovation to enable the regulatory affairs compliance support of new Pernod Ricard products sold in and… more
- AUROBINDO (Dayton, OH)
- …team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs . In addition to several formulations ... and investigations under the direction of a supervisor.8. Comply with all regulatory /in-house requirements (may include but not limited to safety, house keeping,… more
- RPM Research (Solana Beach, CA)
- …to build and lead a QAU . 2+ years of managerial or supervisory experience in quality assurance , regulatory affairs , or compliance oversight. Technical & ... Director, GLP Quality Assurance & Compliance Building a...Director, GLP Quality Assurance & Compliance Building a Culture of ...of In Vivo and In Vitro Research Operations Provide regulatory and quality oversight of in vivo… more
- Twist BioScience (South San Francisco, CA)
- …the platform architecture and infrastructure teams, Manufacturing Operations, Quality Assurance , Process Development, and Regulatory Affairs teams to ... MES professionals, primarily software developers, who work in concert with Manufacturing Operations, Quality Assurance , and R&D. The Director will serve as the… more
- AUROBINDO (Durham, NC)
- …team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs . In addition to several formulations ... under manufacture, we have a robust pipeline of products. Aurolife's aim is to provide healthcare at economical prices to make this a healthier world to live in.Job OverviewThe Human Resources Business Partner will provide support in the following functional… more
- System One Holdings, LLC (Florham Park, NJ)
- …for electronic submissions. Coordinate with cross-functional teams, including Regulatory Affairs , Clinical Development, and Quality Assurance , to obtain ... met. Ability to work collaboratively with cross-functional teams, including regulatory affairs , clinical operations, and quality assurance in a… more
- Pall (Miami, FL)
- …fields with 15 years of progressive Regulatory compliance and / or quality assurance experience.Thorough understanding of ISO 9001 and AS9100 / CAA Part ... the Danaher Business System which makes everything possible.Director Global Quality and Regulatory ComplianceJOB SUMMARYInterprets federal/state/international regulations… more
- Piper Companies (Minneapolis, MN)
- …Biotech, Pharmaceutical Development, 21 CFR 1271, 21 CFR 312, Regulatory Strategy, Regulatory Submissions, Quality Assurance (QA), Quality Control ... Piper Companies is seeking an Associate Director, Regulatory Affairs to join a top biotechnology company in Minneapolis, MN. Responsibilities of the Associate… more
- Abbott (Santa Clara, CA)
- …experience in regulatory preferred but may consider quality assurance , research and development/support, scientific affairs , operations, or related area. ... imaging catheters and software, vessel closure devices and peripheral stents. This Regulatory Affairs Manager position is an onsite opportunity working out… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. JOB SUMMARY The Senior Director, Head Medical affairs Quality Assurance in Global RD/PV QA is accountable to ... stakeholders. The role will manage and or support medical affairs Quality resources (US, Brazil, Japan/ APAC...and compliance Marketing/ commercial GMP QA/ Supply chain / Regulatory Affairs Leadership/ team management: Create a… more
- Abbott (Maple Grove, MN)
- …experience in regulatory preferred but may consider quality assurance , research and development/support, scientific affairs , operations, or related area. ... The Opportunity We are looking for our next Senior Regulatory Quality Specialist to join our team...as attention to detail. Preferred Qualifications Master's Degree in Regulatory Affairs and may be used in… more
- Kailera Therapeutics, Inc. (Waltham, MA)
- …You'll Do: Playing a critical hands-on role within Kailera, the Associate Director, Clinical Quality Assurance will be relied upon as Subject Matter Expert in ... Responsible to collaborate/support with Clinical Operations, Clinical Development, Pharmacovigilance, Regulatory Affairs , Biometrics, and Clinical Pharmacology and… more
- LanceSoft (Pittsburgh, PA)
- …Position Status Label: Hourly Non-Exempt The Sr. Manager, Research and Development (R&D) Quality Assurance will independently perform the duties of the QA ... Program Lead (PL) role, providing Clinical Quality Assurance oversight of assigned clinical studies,...knowledge of Auditing, Clinical Supply Chain, Clinical Operations, Monitoring, Regulatory Affairs , Clinical Research, Drug Safety and… more
- Advocate Aurora Health (Wake Forest, NC)
- …of IRB Professionals (CCIP) when eligible needs to be obtained within 1 year, or Regulatory Affairs (RAC) certification issued by the Regulatory Affairs ... Specialists. Leads and provides guidance in the development and implementation of quality improvement and quality assurance activities. Maintains current… more
- Takeda Pharmaceutical Company Limited (Boston, MA)
- …engineering, analytical/organic/physical chemistry, process engineering, pharmaceutics, quality assurance and/or regulatory affairs . Advanced ... Guidelines, other pertinent national regulations, compendial requirements and communicating with regulatory agencies. Must have experience in global regulatory … more
- City of New York (Corona, NY)
- …priority for the Agency. IHD's Engineering Services includes the Quality Assurance , Laboratory Services, Specifications/Standard Operating Procedures, ... to regularly modify and update the documents. The specification program is also responsible for quality assurance and quality control to ensure that in house… more
