- Jazz Pharmaceuticals (Redwood City, CA)
- …a strategy to pre-empt compliance issues. Partner with GRADS Alliance Management to review metrics provided by GRADS Regulatory Affairs, Regulatory ... achieve compliance, inspection readiness, and continuous improvement across the Regulatory and Labeling organizations. Essential Functions/Responsibilities Responsible for all… more
- Hawaiian Electric (Honolulu, HI)
- Associate General Counsel or Senior Associate General Counsel (Litigation & Regulatory ) - Oahu Date:Oct 11, 2025 Location: Honolulu, Hawaii (HI), US, 96813 ... either the Associate General Counsel or Senior Associate General Counsel (Litigation & Regulatory ) -...legal services and monitoring of potential areas requiring legal review . Provide such other services as attorney's abilities, education,… more
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position?** Reporting to the Director in Organon Regulatory CMC,?the Associate Principal Scientist is responsible for?developing ... regulatory strategies by leading the development, authoring and review of CMC submission components and documentation to support post-approval supplements,… more
- Organon & Co. (Jersey City, NJ)
- …**The Position** Reporting to the Director or Executive Director in Organon Regulatory Chemistry, Manufacturing and Controls (CMC), the Associate Principal ... regulatory strategies by leading the development, authoring and review of CMC submission components and documentation to support post-approval supplements,… more
- Jazz Pharmaceuticals (Philadelphia, PA)
- …www.jazzpharmaceuticals.com for more information. Brief Description: The Associate Director position, Regulatory Affairs Global CMC is responsible for ... commercial and development projects in line with the global regulatory strateg y . The Associate Director...for team products , and manage the preparation and review of material for agency interactions . Provide… more
- Terumo Aortic (Sunrise, FL)
- Regulatory Affairs Associate II Date: Oct...the preparation of US, EU, and rest of world regulatory submissions as required. + Review proposed ... the lives of patients in over 100 countries worldwide. www.terumoaortic.com JOB TITLE Regulatory Affairs Associate II DEPARTMENT Regulatory Affairs JOB CODES… more
- Cipla (Hauppauge, NY)
- …other benefits. Shift: Second Shift - 3:00pm - 11:30pm Job Overview: The QA Associate (Reviewer) is responsible for review of batch production records, ensuring ... working outside of Cipla's US Subsidiaries or Affiliates. Job Title: QA Associate (Reviewer) Location: 7 Oser Avenue Hauppauge, NY (Onsite) Employment Type:… more
- Insmed Incorporated (NJ)
- …and for the future of science, we're in. Are you?About the Role:The Associate Director, Clinical Research Scientist will support and work predominately with the ... This individual will provide scientific support to clinical development and operations, regulatory and quality assurance teams, as well as overall program support… more
- Merck & Co. (Rahway, NJ)
- …Source Management Business Operations Lead is expected to understand the end-to-end regulatory submission process. The main focus will be on document production ... processes, including content authoring, review and finalization, and feed to the Submissions Assembly...industry experience, at least 6 of those in a regulatory and/or compliance area and experience with technical systems… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …implementation of obligations deriving from these contracts. Organize and conduct periodic review of contract quality and adherence PV Regulatory Intelligence: ... language in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Oversees the management of PV … more
- Insmed Incorporated (NJ)
- …the future of science, we're in. Are you?About the Role:The Associate Director, Programming provides technical leadership and ensures adequate programming support ... Collaborates with cross-functional team members within Biometrics, Clinical Operations, Regulatory , and Clinical Development, as well as with external vendors.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Novo Nordisk Inc. (Boulder, CO)
- …, Analytical Development, Materials Management, and Clinical Supply Write, review , and/or approve Standard Operating Procedures, specifications, regulatory ... of both worlds to develop new medicines for patients. The Position The Associate Director of Drug Product Manufacturing is accountable for all clinical drug product… more
- Merck & Co. (Rahway, NJ)
- …DescriptionReporting into the Director, Logistics and Distribution Technology the Associate Director, Logistics and Distribution Technology will be responsible and ... to shape the technical capabilities lead a global, cross-modality technical team.The Associate Director will lead a team of technical experts responsible providing… more
- Eisai, Inc (Houston, TX)
- …including training, career evaluation, coaching, mentoring, performance management and talent review . Ensure compliance with regulatory and other ethical ... If this is your profile, we want to hear from you. The Associate Director/Director, MSLs is responsible for the leadership, direction and management of MSLs… more
- Merck & Co. (Durham, NC)
- Job DescriptionQuality Assurance Associate SpecialistOur Quality Assurance group ensures every single material inside our products is manufactured, processed, ... our incredibly high standards of quality and meets all regulatory requirements. Partnering across our-internal manufacturing facilities, external contract… more
- Lupin Pharmaceuticals (Coral Springs, FL)
- …profile (TPP) development, due diligence projects, and clinical- regulatory compliance. ResponsibilitiesEssential Duties and Responsibilities Clinical Development: ... execute clinical trials for respiratory products, ensuring compliance with regulatory requirements.Collaborate with cross-functional teams to develop study protocols,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence to the protocol, Good Clinical ... process in evaluating study budgetsCollect information and coordinate with DS Regulatory Operations to post trial information on required public forums… more
- American Career College (Irvine, CA)
- Reporting to the University Director Student Affairs, the Associate University Director, Student Rights serve as proxy for University Director of Student Affairs for ... oversee and ensure Student Rights and Responsibilities compliance with all regulatory agencies, state and governing boards and accrediting bodies, including but… more
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