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Kelly® Science & Clinical is seeking a Director of Regulatory Affairs for a fulltime, Direct Hire role with a pharmaceutical client based in San Fran Bay area.. Position Overview: The Global Regulatory Affairs Director will play a pivotal role in leading and managing our global regulatory strategy to ensure the successful approval and commercialization of our promising HBV small molecule drug.. Monitor changes in the regulatory landscape and assess their impact on ongoing and future drug development activities.. BS/MS/PhD in Life Sciences, Pharmacology, Pharmacy, or a related degree. In-depth knowledge infectious disease related therapeutic areas is a plus.
The Executive Director, Head of Regulatory Affairs will be responsible for overseeing all regulatory affairs activities related to the development of innovative small molecules for the treatment of cancer.. Lead all aspects of regulatory affairs, including growing a high-performing regulatory team to support the development and approval of multiple pipeline assets.. Develop and implement regulatory strategies for drug development that align with business objectives and timelines.. Provide expert regulatory guidance to cross-functional teams, including clinical development, CMC, and quality assurance.. Minimum of 10 years of experience in regulatory affairs, with specific experience in oncology drug development.
As the Director, Regulatory Affairs CMC, reporting to the Senior Director, Regulatory Affairs CMC, you will be responsible for developing and executing the CMC regulatory strategies for Olema product(s) in development and post-approval. You will provide CMC regulatory strategy support and guidance to cross-functional teams within the organization. Provide CMC regulatory expertise for global development and registration programs (e.g., INDs, CTAs, BLAs and MAAs). 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. Global CMC regulatory experience for clinical trials is required.
The Vice President of Regulatory Affairs will be responsible for developing and implementing regulatory strategies to ensure that Xenter's medical devices meet all regulatory requirements in global markets. Lead the Regulatory Affairs team, providing direction, mentorship, and professional development opportunities. premarket approval (PMA) applications, and international submissions. Collaborate with R&D, Quality Assurance, Clinical Affairs, and Marketing teams to ensure regulatory requirements are integrated into product development and commercialization processes. Minimum of 10 years of experience in regulatory affairs within the medical device industry, with at least 5 years in a senior leadership role.
This leadership role requires strategic thinking, operational excellence, and an ability to collaborate across function teams to advance our drug development pipeline.. Collaborate with cross-functional teams (e.g., Regulatory Affairs, Data Management, Biostatistics) to ensure seamless execution of clinical trials.. BS/MS/PhD in Biology, Biochemistry, or Pharmacology or related degree. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability.. It’s the ripple effect that changes and improves everything for your family, your community, and the world.
The Head of Regulatory Affairs is a leadership position responsible for the strategic oversight of all regulatory affairs activities related to the development and registration of company products. Regulatory submissions: Organize and oversee the preparation, review, and submission of regulatory documents to regulatory authorities, including Investigational New Drug (IND) applications, New Drug Applications (NDAs), Biologics License Applications (BLAs), Marketing Authorization Applications (MAAs), and other relevant submissions. Cross-functional collaboration: Collaborate with and provide guidance to cross-functional teams including research, development, clinical operations, quality assurance, and CMC teams to ensure regulatory requirements are integrated into development plans, clinical trials, manufacturing processes, and labeling. Extensive experience (12+ years) in the biotech or pharmaceutical industry, with a focus on non-clinical and clinical development; minimum of 10 years in oncology regulatory affairs required; additional experience in infectious diseases preferred. Strong knowledge of preclinical research, pharmacology, toxicology, and clinical development processes.
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.
Orbital Therapeutics is seeking a dynamic and experienced Senior Director/Vice President of Regulatory Affairs to lead the company's regulatory strategy and advise on the company's quality strategy and operations.. The ideal candidate will have deep expertise in regulatory affairs and complementary experience in quality assurance and control within the biotechnology or pharmaceutical industry.. Ensure regulatory oversight of clinical trials to guarantee compliance with Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and Good Laboratory Practice (GLP) standards.. Experience in RNbased or gene therapy products is highly desirable.. Strong understanding of quality systems and regulatory compliance in drug development.
Eagle Global Scientific is seeking a Technical/Research Regulatory Affairs Specialist/Subject Matter Expert for Food and Drug Administration (FDA) (Part-Time, Remote). Work in preparing one's own research proposals and one's own submissions to an IRB office or to the FDA and managing one's own research portfolio will not meet the qualifications required by this section.. 3 years current (within the past 5 years) personal and direct experience in FDA clinical research protocol compliance administration and shall have personally conducted FDA focused regulatory affairs quality assurance audits of customer's research projects.. Shall meet all technical and experience prerequisites to be qualified to test for Regulatory Affairs Professional certification, such as Certified Clinical Research Professional (CCRP), Research Regulatory Affairs Professional (RAP) or other like-kind industry standard certification.. Contractor shall have prior experience in the development, planning, hosting and delivering FDA research regulatory affairs training and education materials, including but not limited to web-site materials, workshops, training presentations, and quality assurance visits and discussions related to administration of clinical trial research records.
Orbital Therapeutics is seeking a dynamic and experienced Senior Director/Vice President of Regulatory Affairs to lead the company's regulatory strategy and advise on the company's quality strategy and operations.. The ideal candidate will have deep expertise in regulatory affairs and complementary experience in quality assurance and control within the biotechnology or pharmaceutical industry.. Ensure regulatory oversight of clinical trials to guarantee compliance with Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and Good Laboratory Practice (GLP) standards.. Experience in RNbased or gene therapy products is highly desirable.. Strong understanding of quality systems and regulatory compliance in drug development.
Quality Assurance Compliance Specialist – Medical Devices. We are supporting a U.S.-based medical device manufacturer that designs and builds high-specification Class II medical devices within Respiratory for hospital and clinical environments.. Known for engineering excellence and a strong commitment to regulatory compliance, the company has a long-standing reputation for delivering safe, effective, and durable systems that support patient care in critical settings.. As part of their ongoing growth, the company is seeking a Quality Assurance Compliance Specialist to join their onsite team in Riviera Beach, Florida.. In-depth knowledge of MDD/MDR, CE/CSA standards
This is a contract job opportunity.. Rotating weekends Job is at a clinical research facility Preparing for upcoming studies, service healthy population of patients during clinical trial studies, dosing, watching for side effects to trials, administering trial doses, reporting and investigating side effects.. This would be the perfect fit for those looking to transition from hospital settings into nursing lab settings.. Working with only healthy population of candidates during medical dosing trials.. Must be proficient with computers and electronic charting as Nurses are required to document trial doses and effects into computer systems
This is a contract job opportunity.. This would be the perfect fit for those looking to transition from hospital settings into nursing lab settings.. Working with only healthy population of candidates during medical dosing trials.. Must be proficient with computers and electronic charting as Nurses are required to document trial doses and effects into computer systems
The Vice President, Regulatory Affairs is responsible for developing and overseeing global strategies, RA operations, and global labeling to secure IND/CTA approvals for various studies as well as obtain and later maintain market approval for product(s) in oncology. Oversees Labeling Regulatory staff / contractor(s)Demonstrates excellent understanding of drug development in oncology and leadership behaviors consistent with level.. Provides coaching, management, and mentoring for regulatory affairs team members.. Doctorate or Master’s degree in life sciences (pharmacy, biology, chemistry, medicine pharmacology) or related field.. Minimum of 15+ years' experience in pharmaceutical regulatory activities in oncology, with experience as lead regulatory product strategist in two or more major regions in addition to the US, such as EU, Japan, or China
Our direct client is looking for a Director of Quality Assurance (IVD & FDA) that has a background with In Vitro Diagnostics (IVD) devices.. Our client, an innovative and well-funded IVD company, is seeking a Director of Quality Assurance with expertise in In Vitro Diagnostics (IVD) devices and FDA compliance.. This leader will oversee and grow the company's QMS, ensuring alignment with global regulations (Health Canada, FDA, EU) as they prepare for clinical trials and product launch in 2025.. Oversee new product development, including R&D, prototyping, clinical trials, validation, and commercialization.. 10 + years of overall experience in Quality Assurance within Life Science Industry (pharmaceutical, biotechnology, medical devices, or In Vitro Diagnostics (IVD) Industry)
Hoxworth Blood Center (HBC) was founded in 1938 and serves more than 30 hospitals in 18 counties in Southwestern Ohio, Northern Kentucky, and Southeastern Indiana.. In partnership with the UC Health academic healthcare system and Cincinnati Children's Hospital Medical Center, UC COM's faculty and staff are transforming the world of medicine every day.. Hoxworth Blood Center, University of Cincinnati, Division of Quality Assurance is seeking a full-time Director, to oversee and direct the coordination of quality assurance and regulatory compliance for the collection, manufacture, storage and distribution of licensed and unlicensed blood and blood components, and for the testing of donor and patient samples.. Support the Division Director in the preparation of license applications to the FDA, the annual report of minor changes to the FDA, and necessary correspondence with the FDA.. Job Segment: Regulatory Affairs, Quality Assurance, QA, Quality Manager, Compliance, Legal, Quality, Technology
Usona Institute, a non-profit medical research organization founded in 2014, conducts and supports biochemical and clinical research to further the understanding of the therapeutic effects of psilocybin and other consciousness-expanding medicines.. Our focus is on alleviating depression and anxiety in people for whom current medical treatments fall short in offering relief and a better quality of life.. The Director, Quality Assurance provides strategic and operational regulatory leadership for Usona Institute's psychedelic drug development activities.. Minimum of 10 years of progressive Regulatory Affairs experience in the pharmaceutical or biotechnology industry.. Demonstrated experience with FDA regulatory submissions (e.g., IND, NDA) and successful agency interactions.
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.
This is a contract job opportunity.. Rotating weekends Job is at a clinical research facility Preparing for upcoming studies, service healthy population of patients during clinical trial studies, dosing, watching for side effects to trials, administering trial doses, reporting and investigating side effects.. This would be the perfect fit for those looking to transition from hospital settings into nursing lab settings.. Working with only healthy population of candidates during medical dosing trials.. Must be proficient with computers and electronic charting as Nurses are required to document trial doses and effects into computer systems
This is a contract job opportunity.. schedule Job is at a clinical research facility Preparing for upcoming studies, service healthy population of patients during clinical trial studies, dosing, watching for side effects to trials, administering trial doses, reporting and investigating side effects.. This would be the perfect fit for those looking to transition from hospital settings into nursing lab settings.. Working with only healthy population of candidates during medical dosing trials.. Must be proficient with computers and electronic charting as Nurses are required to document trial doses and effects into computer systems