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The Vice President of Safety and Regulatory Affairs is a senior executive responsible for leading the hospital's enterprise-wide strategies in patient safety and regulatory compliance. The VP of Safety and Regulatory Affairs also directs development and implementation of a system wide accreditation program to ensure continuous compliance with all federal and state regulatory standards (The Joint Commission, CMS, DPH, MA BORIM). Serve as the primary liaison with legal counsel on claims, litigation, and potential liability exposure. Ensure organizational compliance with all regulatory standards related to patient safety and risk, including The Joint Commission (TJC) , Centers for Medicare & Medicaid Services (CMS) , OSHA , and state health departments. Certified Professional in Healthcare Risk Management (CPHRM), Certified Professional in Patient Safety (CPPS), or related credential.
As the Director, Regulatory Labeling, reporting to the Vice President, Regulatory Affairs and Quality Assurance you willlead thedevelopmentof labelingfor clinical suppliesas well as development of commercial labeling materialsforOlema products. This role requires a solid understanding of global labeling requirements, labeling platforms, and print production processes to effectively manage end-to-end label implementation. This role will work closely internally with Regulatory Affairs, Clinical Development, Clinical Supply (CS), Quality Assurance (QA), and the CMC teams as well as external vendors (clinical research / development and manufacturing organizations) to ensure appropriate quality control checks are proceduralized and implemented for all labeling activities. Serve as a strategic cross-functional partner working closely with the CMO/CRO labeling specialists, cross-functional project teams including Quality, Regulatory, Clinical Supply and CMC teams.. 10+ years of experience working in clinical research, biotech, and/or pharmaceutical company, with 8+ years of Regulatory Affairs experience within clinical research or pharmaceutical
The Senior Director, Regulatory Affairs will lead the Global Regulatory Team for an assigned program and work cross-functionally with Clinical Research, Drug Safety, Biometrics, Quality, Medical Affairs, and others to advance the development, approval and lifecycle management of assigned programs. This position will report to the Executive Director of Regulatory Affairs. Reviews sections of IND/CTA, NDA/BLA/MAA, and other global submission documents in support of clinical trials and marketing applications, and their amendments in conformance with local regulatory requirements.. 12+ years of drug development and regulatory affairs experience in the Biotech/ Pharmaceutical industry. Bachelor of Science in a scientific discipline; advanced degree MD, PharmD, or PhD preferred
This role is part of the RA New Product Introduction (NPI) team, reporting to the Director of Global NPI and U.S. Regulatory Affairs. Bachelor's degree, preferably in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred. 7+ years' experience in a regulated industry, +7 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. Associate Regulatory Affairs Manager (San Diego) Associate Director of Regulatory Affairs Associate Director of Regulatory Affairs Associate Director, Regulatory Affairs CMC San Diego County, CA $140,000.00-$170,000.00 2 weeks ago.. Associate Director, Regulatory Affairs CMC Associate Director Regulatory Affairs CMC Regulatory Affairs Manager - IVD and 510K Manager/ Sr. Manager, Regulatory Affairs Manager, Regulatory Affairs - Hybrid - 134458 Manager, Vendor Contracts & Regulatory Affairs Manager, Regulatory Affairs - Hybrid - 134458 EPMO Project Manager - Work in Regulatory andMedical Affairs domains We’re unlocking community knowledge in a new way.
Uses extensive knowledge of US, EU, APAC and ICH regulatory requirements and the ability to apply knowledge both strategically and operationally to development projects and marketed product regulatory issues to support corporate strategy. Reviews sections of IND / CTA, BLA / MAA, and other global submission documents in support of clinical trials and marketing applications, and their amendments in conformance with local regulatory requirements. Liaises and negotiates with global regulatory authorities as needed for all aspects pertaining to drug development including resolution of key regulatory issues and to expedite product approvals and labeling. Ph. D. and 10+ years of work experience in pharmaceutical regulatory affairs, or B.S / M.S. and 12+ years of work experience in biotech or pharmaceutical regulatory affairs.. Preferred candidates will have experience working as a senior leader in Regulatory Affairs across two or more major geographic areas and prior experience with both small molecules and biologics.
Coordinates global CMC regulatory activities necessary to conduct clinical trials, achieve marketing approval of drug candidates and ultimately support the life-cycle of approved products.. Supports CMC regulatory affairs activities for marketed products and compounds in development in line with US and ex-US regulatory requirements.. Supports the regulatory function on development teams providing CMC regulatory guidance and strategy including identifying and assessing/mitigating regulatory risks.. Targeting at least 8 years of progressively responsible experience in CMC Regulatory Affairs with a focus on small molecule drug development.. Previous experience in the preparation and submission of the CMC components of IND/CTA and NDA and ex-US MAA submissions.
Coordinates global CMC regulatory activities necessary to conduct clinical trials, achieve marketing approval of drug candidates and ultimately support the life-cycle of approved products.. Supports CMC regulatory affairs activities for marketed products and compounds in development in line with US and ex-US regulatory requirements.. Supports the regulatory function on development teams providing CMC regulatory guidance and strategy including identifying and assessing/mitigating regulatory risks.. Targeting at least 8 years of progressively responsible experience in CMC Regulatory Affairs with a focus on small molecule drug development.. Previous experience in the preparation and submission of the CMC components of IND/CTA and NDA and ex-US MAA submissions.
The company’s R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. The Opportunity:The Director of Regulatory Affairs is accountable for the delivery of regulatory strategy for designated programs at RevMed. They will support programs and drug development teams and ensure delivery of targeted, pragmatic, well-vetted, consistent and actionable regulatory advice. Establish highly collaborative and effective relationships with management colleagues in Clinical Research, Clinical Operations, Regulatory Affairs, Medical Writing, Quality and other functions to ensure cross-functional alignment and team effectiveness. Required Skills, Experience and Education:Degree in life sciences, pharmacy, medicine, or related fields with a minimum of 12 years in the pharmaceutical/biotech industry or relevant work experience and a minimum of 8 years in Regulatory Affairs including regulatory strategy and leadership roles. Direct experience in oncology drug development including oversight of large, global Phase 3 and platform studies.
This position, Associate Director Regulatory Affairs, works out of our San Diego, CA location in the Infectious Diseases Division.. This role is part of the RA New Product Introduction (NPI) team, reporting to the Director of Global NPI and U.S. Regulatory Affairs.. Approve regulatory filing strategies based on proposed preclinical, clinical, and manufacturing changes.. Bachelor's degree, preferably in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred.. 7+ years' experience in a regulated industry, +7 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
Associate Director, Regulatory Affairs Strategy. Building on the company’s leadership in the field of cellular metabolism, Agios is advancing a robust clinical pipeline of investigational medicines with active and planned programs in alpha- and beta-thalassemia, sickle cell disease, pediatric PK deficiency and MDS-associated anemia.. Agios Pharmaceuticals is searching for a dynamic Associate Director, Regulatory Affairs Strategy to join our growing Regulatory team.. Associate Director: Must have minimum of 8 years pharmaceutical industry with 6 years in Regulatory affairs strategy. Strong demonstration of knowledge of drug development, FDA, EMA and ICH guidelines and regulations
Who We Are: MapLight Therapeutics is a clinical stage biotech company that focuses on drug discovery for central nervous system disorders.. We combine cutting-edge technologies including optogenetics, in vivo physiology, and spatial transcriptomics to identify novel drug targets and develop effective therapies to address psychiatric symptoms.. What You’ll Do: Reporting to the VP, Regulatory Affairs, the Executive Director, Medical Writing will establish the function and oversee internal and external medical writing resourcing to support authoring needs.. Responsible for clinical trial transparency and disclosures, including clinical trials results posting on clinicaltrials.gov, EudraCT, and similar databases worldwide, in collaboration with Regulatory Affairs. Working knowledge of drug development, clinical research, study design, biostatistics, regulatory, and medical terminology.
No other company in the world helps more people share professional knowledge or make business connections. Knowledge of API testing using tools like Postman.. Strong wellbeing support through EAP assistance, mental health first aiders, free access to a wellness app and more.. Quality Assurance Manager, RWE Clinical Trials (Remote).. Analyst - Quality Assurance Financial Crime ComplianceSenior QA Engineer, Secure Remote Access TestingAnalyst - Quality Assurance Financial Crime ComplianceSr. Program Manager, Quality Assurance/Regulatory Affairs (Hybrid)
The Senior Director of Global Regulatory Affairs - CMC (GRCMC) leads and manages the scientific and regulatory efforts of the team, overseeing CMC regulatory activities for global submissions and interactions with regulatory authorities for Lilly's synthetic molecule portfolio. Recognized as a deep scientific technical expert in CMC drug development and/or pharmaceutical manufacturing technology and processes. Ensures department has broad technical knowledge and expertise in global CMC regulatory requirements and guidelines for conducting clinical trials, obtaining global product registrations, and updating approved global product registrations for drug substances and drug products. Provides regulatory sciences leadership, decision making, guidance and coaching for CMC regulatory scientists. Ensures that global CMC regulatory commitments are defined based on approved submissions for products and communicated to Manufacturing and Quality Assurance.
The University of California, Los Angeles (UCLA) invites applications for the position of Associate Director of Clinical Theranostics Research at the Assistant or Associate Professor level within the Ahmanson Translational Theranostics Division, Department of Molecular and Medical Pharmacology.. Assume clinical responsibilities, including conventional nuclear medicine, PET/CT and therapeutic and theranostic nuclear medicine services.. Play an integral role in the dosimetry program, integrating personalized radiation dose estimation into clinical research protocols and patient care pathways,. Significant experience in clinical trials, preferably in the theranostic or molecular imaging space.. ACRP certification, expertise in regulatory affairs and regulatory submissions, IND filings, engagement with the FDA, IRB submissions, GCP, and CITI
Verathon, a subsidiary of Roper Technologies, is headquartered in Bothell, Washington, USA and has international subsidiaries in Canada, Europe and Asia Pacific. Verathon is looking for a Director, Regulatory Affairs to become the newest member of our QA/RA Team located in Bothell, WA. This is an onsite position based in our Bothell WA Headquarters. The Director, Regulatory Affairs is responsible for managing regulatory strategies for worldwide device and registration of Verathon products, in accordance with product development and business objectives. Lead, mentor, and develop a team of Regulatory Affairs professionals and contracted clinical study, medical professionals, and other consultants.. 8+ years experience in regulatory affairs within a regulated industry (e.g., medical devices, pharmaceuticals, biotechnology, or healthcare products)
The VP will also lead Medical Affairs activities including clinical studies, Customer Contact Center, and pharmacovigilance.. Product categories include OTC monograph drugs, OTC NDAs, Medical Devices, Cosmetics, Dietary Supplements, and EPregistered products.. The VP, Quality Assurance and Regulatory Affairs will foster close cooperative relationships with all functions in the company relative to compliance, working with Marketing, Product Development, Package Development, Legal, and Operations to execute all product and labeling claims and strategies for the company’s brands.. The VP will lead and apply Quality Assurance and cGMP expertise for OTC drug products (monographed and NDA/ANDA), medical devices, dietary supplements, and cosmetics.. The VP will provide clear direction to Medical Affairs on clinical studies, the Customer Contact Center, and pharmacovigilance.
Join to apply for the Inventory Control & Quality Assurance Manager (Food Industry) role at Conexus Food Solutions.. Conexus Food Solutions is a leader in the Asian food service industry, bringing a diverse range of ethnic cuisines, such as Chinese, Japanese, Korean, and Thai, to the table. Quality Assurance Manager - Steel Manufacturing.. Director, Food Safety and Quality Assurance - Buckhead ChicagoQuality Assurance and Regulatory Affairs Manager.. Quality Assurance Manager, RWE Clinical Trials (Remote)
The company was co-founded in 2022 by Drs. Athena Countouriotis and Mohammad Hirmand (former CEO and CMO of Turning Point Therapeutics, respectively). Reporting to the Senior Vice President, Regulatory Affairs, the Senior Manager/Associate Director, Medical Writing will author, edit and provide input to documents required for regulatory submissions to US and other global health authorities, presentations, posters, publications and regulatory fulfillment. Thorough knowledge of clinical research concepts, practices, and Food and Drug Administration (FDA)/European Medicines Agency (EMA)regulations and International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH)/Good Clinical Practices (GCPs) Guidelines regarding drug development phases, clinical research, and medical writing standards; demonstrated ability to interpret and apply these guidelines to document writing.. A reasonable estimate of the base salary range for this role is $170,000-$179,000 for a Senior Manager and $179,000 – $187,000 for an Associate Director. Medical Science Liaison, Wound Care, San Diego.
Verathon, a subsidiary of Roper Technologies, is headquartered in Bothell, Washington, USA and has international subsidiaries in Canada, Europe and Asia Pacific. Verathon is looking for a Director, Regulatory Affairs to become the newest member of our QA/RA Team located in Bothell, WA. The Director, Regulatory Affairs is responsible for managing regulatory strategies for worldwide device and registration of Verathon products, in accordance with product development and business objectives. Lead, mentor, and develop a team of Regulatory Affairs professionals and contracted clinical study, medical professionals, and other consultants. 8+ years experience in regulatory affairs within a regulated industry (e.g., medical devices, pharmaceuticals, biotechnology, or healthcare products).
The Associate Director, Medical Writing is expected to deliver high quality regulatory documents in accordance with regulatory guidelines that meet ICH standards, project timelines, and specifications set forth for the projects and to act as a Medical Writing coordinator for the preparation of drug safety-related documents.. The responsibilities also include the coordination and preparation of Meeting Content Packages and responses to regulatory authorities as well as the management and preparation of a variety of clinical documents, including clinical study reports, narratives, investigator’s brochures for Phase I to IV clinical trials, and drug safety-related documents.. Competency in the use of Documentum (or a similar document management system) is required, while some knowledge or experience with electronic publishing tools is desired.. Competency in the use of Documentum (or a similar document management system) is desired.. Teams within the Global Groups and Medical and Regulatory Affairs department: Medical Planning and Management Physicians, Clinical Research, Data Management, Biostatistics, Drug Safety and Pharmacoepidemiology, Regulatory, Preclinical Research.