- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with relevant regulations. This role will work with Global Regulatory Affairs and cross-functional teams (eg, Quality , CSPV, Clinical Operations, Clinical ... centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key... will be a key member of the Global Regulatory Affairs (GRA) Process Excellence & Analytics… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …CSPV and external functions including Clinical Development, Research Development, Regulatory Affairs .Facilitate operational meetings with CROs, License Partners, ... deriving from these contracts. Organize and conduct periodic review of contract quality and adherence PV Regulatory Intelligence:Contribute to the management of… more
- Merck & Co. (North Wales, PA)
- …work collaboratively with other leaders in Clinical Development and Global Regulatory Affairs .--The AVP provides leadership and direction through senior-level ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Katalyst HealthCares and Life Sciences (Southern Md Facility, MD)
- …Degree in life sciences or engineering, or other technical discipline. 6 years of Regulatory affairs job experience in the medical device industry. Technical or ... Medical Writing experience. Must be familiar with relevant US/international regulatory requirements for medical devices including Quality Systems standards and… more
- Katalyst HealthCares and Life Sciences (Newark, NJ)
- Responsibilities: The Regulatory Affairs Manager is responsible for the development and execution of global regulatory strategy and tactical planning for ... report to the Sr. Director QRC responsible for microbiology quality , regulatory , and clinical. If you thrive...role and want to work to build a world-class Regulatory Affairs organization-read on. Responsible for a… more
- Abbott (Santa Clara, CA)
- …catheters, imaging catheters and software, vessel closure devices and peripheral stents. This Regulatory Affairs Manager position is an onsite opportunity ... years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs , operations, or related… more
- Kyowa Kirin North America (Princeton, NJ)
- …with offices in California, North Carolina, and Mississauga, Ontario. Summary: The Project Manager , Global Regulatory Affairs Compliance and Planning will ... for timely monitoring and reporting of project performance. Essential Functions: The Project Manager , Regulatory Affairs Global Compliance and Planning is… more
- Katalyst HealthCares and Life Sciences (Cambridge, MA)
- …ensure timely and appropriate resolution of the issues. Experience with the dynamic regulatory landscape, especially in CMC and quality aspects. Expertise in ... Lead the strategic efforts in the interpretation of relevant and new quality guidelines to ensure that the current and phase appropriate requirements and… more
- Trinity Health (Silver Spring, MD)
- …language and communicate verbally, electronically and on hard copy. Reports to: Manager , Accreditation and Regulatory Affairs Pay Range: $33.73-$50.59 ... and staff to maintain survey readiness and promote a culture of continuous regulatory compliance and quality improvement. Job Title: Regulatory ,… 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 and/or ... regulatory teams, legal, Brand Companies, and global Innovation to enable the regulatory affairs compliance support of new Pernod Ricard products sold in and… more
- Syneos Health Careers (Morrisville, NC)
- …employees or applicants to perform the essential functions of the job. Summary Regulatory Submission Manager within the Vertex Regulatory Operations team. ... Description senior regulatory consultant Syneos Health(R) is a leading fully...to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern… more
- Cepheid (Miami, FL)
- …, and other Quality related functions.This position reports to the Sr. Manager Regulatory Compliance and Post Market Surveillance and is part of the ... degree in field with 2+ years of related work experience.Functional knowledge of Quality , Regulatory Compliance, and operations systems and processes to include… more
- Tandem (San Diego, CA)
- …reduce cost and timelines for content localization. As a member of the Regulatory Affairs function, this position collaborates closely with internal stakeholders ... not in office. A DAY IN THE LIFE: The Global Labeling & Translations Manager serves as an expert in localizing regulated product labeling materials required in… more
- Mindlance (Raritan, NJ)
- …creation of project value propositions as needed. Provides strong connectivity with Medical Affairs , R&D, Regulatory Affairs , and Clinical Affairs ... are searching for the best talent for a Project Manager Scientific Operations, located in Raritan, NJ. Remote worker...team across franchises. Ensures deliverables are linked to appropriate Quality Systems and Regulatory Processes to ensure… more
- Zenas BioPharma (Waltham, MA)
- …KOL engagement) Manage cross-functional initiatives with teams like R&D, Commercial, and Regulatory Affairs . Facilitate collaboration between Medical Affairs ... Excellence and Innovation - TRUE Innovation ! Position Summary: The Senior Manager /Associate Director of Medical Operations will oversee the execution of Medical … more
- Veterans Health Administration (Nashville, TN)
- …located at our Nashville campus in our Specialty Clinic. The Nurse Manager Medical Specialty Care is a designated first-line supervisory authority, responsibility, ... of care and practice, the work environment, and accreditation and regulatory standards Additional duties and responsibilities as assigned Preferred Experience:… more
- Orca Bio (Sacramento, CA)
- … quality , supply chain, engineering, MS&T (Manufacturing Science & Technology), and regulatory affairs as needed to coordinate projects. Develop and maintain ... updates, validation, and monitoring project effectiveness. Ensure compliance with GMP, regulatory standards, and internal quality systems throughout project… more
- RPM Research (Solana Beach, CA)
- …and lead a QAU . 2+ years of managerial or supervisory experience in quality assurance, regulatory affairs , or compliance oversight. Technical & Leadership ... up to full compliance. Reporting to the Test Faciliyt Manager , this leader will develop policies, oversee audits,...of In Vivo and In Vitro Research Operations Provide regulatory and quality oversight of in vivo… more
- Skytron LLC (Grand Rapids, MI)
- …and relationships with manufacturers, suppliers, and freight partners Collaborate cross-functionally with Quality , Regulatory Affairs , and Sales teams to ... A supportive, family-owned work environment What You'll Do As the Purchasing Manager , you'll lead strategic procurement and supply chain operations to ensure… more
- US Bank (Minneapolis, MN)
- …at-all from Day One. Job Description The Corporate Audit Services (CAS) Senior Audit Manager - Corporate Function - Other is a management position that supports the ... Corporate Functions, Regulatory Reporting, and SOX Administration Audit Director. This role...responsible for auditing various areas within Strategy and Corporate Affairs . Specific areas of audit responsibility include M&A, DEI,… more
