Collecting information
Organizing data
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
Fosters effective and productive communication among various Regulatory Affairs groups including Regional Regulatory Leads, Regulatory CMC, Labeling, Advertising and Promotion, Regulatory Operations, Medical Writing, and representatives from other functional areas, as appropriate.. Senior Regulatory Affairs Specialist - Vascular (on-site)Quality Assurance & Regulatory Affairs Manager. Sr Regulatory Affairs Specialist (Ad/Promo) (Remote) - Shockwave. Senior Regulatory Affairs Manager – APAC - Diabetes CareSr Regulatory Affairs Specialist - Shockwave Medical. Senior Regulatory Affairs Specialist – Vascular (on-site)Compliance Manager, Regulatory Change ManagementManager, Regulatory Affairs Advertising and PromotionRegulatory Affairs Manager – Vascular (on-site)
Theradex Oncology is a full-service CRO, conducting early and late-phase oncology trials in the U.S, Europe and Asia. Theradex Oncology was founded in 1982, when we were awarded the Clinical Trials Monitoring Contract for the National Cancer Institute (NCI).. We are seeking a Regulatory Affairs Manager/Sr Manager.. Liaison with other departments within Theradex, including Data Management, Medical Writing Pharmacovigilance, Quality Assurance and Drug Distribution. Supports clients in preparing for advice meetings with national RAs or the European Medicines Agency. Maintains an awareness of the literature on cancer therapy, clinical trial design and conduct, Good ClinicalPractice, and regulations and guidelines relating to the conduct of clinical trials
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
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.
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).
As the Director, Regulatory Labeling, reporting to the Vice President, Regulatory Affairs and Quality Assurance you will lead the development of labeling for clinical supplies as well as development of commercial labeling materials for Olema products.. 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. IndustriesBiotechnology Research and Pharmaceutical Manufacturing
We are currently seeking a Regulatory Affairs Associate to be responsible for the planning, development, direction, delivery, evaluation, and coordination of activities within our Regulatory Affairs Department. Handle activities of the Special Investigation Unit (SIU), including reporting and internal investigations. Juris Doctorate Required.. Minimum 3 years of experience in managed care contracting, credentialing, and compliance. Strong knowledge of MLTC, MAP, Medicaid, and Medicare programs.
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.
Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC-RA, labeling, medical writing, regulatory operations, etc.). Knowledge and experience with preparation of global regulatory submissions (IND, CTA, NDA or BLA, MAA).. Solid working knowledge and understanding of the drug development process, laws, regulations, and guidelines including FDA, ICH, etc.. Bachelor's degree with 5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (e.g., clinical development, project management, quality assurance, etc.). If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: , or your local authorities.
We're hiring a Quality Assurance and Regulatory Affairs Manager. We are seeking a Quality and Regulatory Affairs Manager (QA/RA Manager) to lead our quality assurance and regulatory compliance efforts.. ASQ Certified Quality Auditor (CQA) and/or Certified Quality Engineer (CQE).. Manage RMA, QC Inspection, document control, acceptance activities, calibration, QMS training, and quality engineering functions.. Oversee post-market surveillance, adverse event reporting, internal and external audits.
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. 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. Administrative Director - General Surgery, Colon & Rectal Surgery, Plastic SurgeryExecutive Director, NEBMA and Medical Staff ServicesExecutive Medical Director, Immunology Cell Therapy, Neuroinflammation, Multiple Sclerosis
Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. 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 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. 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.
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 companys 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.
Quality Assurance Specialist I (1st Shift).. Quality Assurance Manager, RWE Clinical Trials (Remote).. Quality Assurance (QA) Compliance Specialist II. Quality Assurance and Regulatory Affairs Manager.. Quality Document Control Specialist - Required EDMS, Master Control Exp (Onsite)
Our location in Plano, TX, Austin, TX, Santa Clara, CA, Sylmar CA or Maple Grove, MN currently has an opportunity for a Clinical Evaluation - Senior Project Manager. Facilitate communication and exchange of documents between stakeholders (e.g., internal personnel such as Regulatory Affairs, R&D Engineering, Clinical Engineering, A&P and Marketing, Library Services, Quality Engineering, Post-market Surveillance Group, Clinical Affairs, Risk Management, Program Management, as well as external vendors such as CROs, Medical Writers and Physician Reviewers). Minimum 2 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields. 5-7+ years of experience in clinical research, clinical affairs, regulatory affairs, or quality systems, in the medical device or pharmaceuticals industry.
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.
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)
Further, the Vice President, Regulatory Affairs & Quality Assurance, is responsible for building and mentoring a high-performing team while assuring that ORIC is compliant with federal and state legislation, health authority regulations and guidances, and driving a culture of quality and accountability across the organization.. Provide oversight for global regulatory affairs in all major regions (North America, Europe, Asia Pacific, Latin America) for all regulatory functions, including Clinical, Non-clinical, Regulatory Operations, and broad oversight for Regulatory CMC and Regulatory Diagnostics. Ensure high‐quality and timely regulatory submissions (IND/CTA/NDA/MAA/PMA) in compliance with all applicable regulatory requirements, and in alignment with corporate goals. Demonstrated success leading major regulatory submissions (NDA/BLA/MAA) through approval. Strong experience with GXP compliance and building quality systems (QMS) in a development-stage and/or commercial environment