Collecting information
Organizing data
The Director of Regulatory Affairs (RA) Labeling will lead the development of a cross-functional labeling strategy for products worldwide, including providing expert input on labeling requirements and strategic guidance during label development, facilitating cross functional labeling discussions with Labeling Management Team (LMT) and Executive Labeling Committee (ELC), and participating in label-related Health Authority negotiations.. Guide, develop and author draft labeling text (e.g. USPI, PPI, Med Guide, EU SmPC, EUPIL) to support marketing applications and labeling update of approved package inserts to support product lifecycle management. Define and implement a labelling review and approval process, including documentation of label history, LMT/ELC decisions, and exceptions from CCDS to facilitate end to end global labeling process. Ensure labeling strategy is aligned with overall regulatory and program strategy by working collaboratively with key internal stakeholders, including but not limited to Regulatory Affairs, Clinical Research, Drug Safety, Quality, Commercial, Medical Affairs, Legal, Manufacturing, and Supply Chain. Oversee or otherwise lead and facilitate cross-functional labeling and related forums and meetings, such as LMT and ELC to support draft Label development
Develop and execute global CMC regulatory strategies in alignment with overall product development and registration plans.. Provide CMC regulatory guidance and support to internal teams including manufacturing/MSAT, Quality Assurance, and R&D.. Review and approve CMC regulatory documentation, ensuring compliance with regulatory requirements.. Provide CMC regulatory support for post-approval CMC-associated commitments as well as post-marketing CMC activities.. Knowledge and experience with authoring and preparation of global regulatory submissions (IND, CTA, BLA, MAA), post-approval and post-marketing regulatory CMC activities.
Collaborate with marketing to review and approve product marketing claims, ensuring compliance with FDA regulations and guidelines.. Collaborate with the quality team to ensure that the company’s Quality Management System (QMS) meets regulatory requirements and is effectively implemented.. Review complaint decision trees and handle regulatory reporting of events.. Work closely with R&D, Quality, Marketing, Clinical, Market Access, and other departments to align regulatory activities with business objectives.. 7+ years of experience in regulatory affairs within the medical device industry, with a focus on U.S. FDA submissions and clearances.
Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases.. The Senior Manager / Associate Director of Clinical Quality Assurance Auditor is responsible for partnering with cross-functional teams to manage the audit program and conducting audits (routine & for-cause clinical investigator site, vendor, CSR, and internal audits).. Under the direction of the Executive Director of Clinical Quality Assurance, establish key processes and maintain the Nurix GCP QA audit program, policies, and procedures.. Ensure compliance with applicable health authority regulations and guidelines for document management, TMF, and software used in GCP processes.. Deep knowledge and understanding of drug development process, global regulations, and interfacing related to GXP, and GCP authorities.
89bio is a clinical-stage biopharmaceutical company dedicated to the development of best-in-class therapies for patients with liver and cardiometabolic diseases who lack optimal treatment options.. The Associate Director will work closely with and report to the Vice President of Regulatory Affairs.. Lead preparation of and ensuring accuracy, completeness, and timeliness of high-quality submissions to US FDA including INDs, IND amendments, annual reports, special designations (orphan, breakthrough, fast track), responses to Health Authority queries.. Collaborate with clinical operations, clinical development, clinical quality assurance, pharmacovigilance team to oversee global clinical trials managed by contract research organizations.. Background investigations are required for all positions by 89bio, consistent with applicable law.
The Director will be the Category Leader for the category assigned to them within the Strategic Sourcing and Procurement (SS&P) department.. This individual will be the key point of contact for their category and will be responsible for providing strategic leadership, operational oversight, and administrative/HR management for direct reports and extended leadership for indirect reports.. The Director, Sourcing will be a Category Leader for the Development Category encompassing Clinical Labs, Clinical Pharmacology, Translational Research, Global Patient Safety, Regulatory Affairs, Medical Affairs, Clinical Development, and Biometrics.. This role will support outsourcing needs to advance Exelixis R&D efforts, including services such as consulting, medical science liaison, pharmacovigilance, quality assurance, central labs, local lab results integration, PK and immunogenicity bioanalysis, biomarker assays, ADME studies, and toxicology.. Deep knowledge of outsourcing concepts, financial processes, contracts, regulations (FDA, EMA, ICH GCP), and industry standards.
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.
Sr Regulatory Affairs Specialist (Ad/Promo) (Remote) - Shockwave. Senior Regulatory Affairs Specialist -Vascular (on-site). Senior Regulatory Affairs Specialist – Vascular (on-site). Regulatory Affairs Manager – Heart Failure (on-site). Regulatory Affairs Manager – Vascular (on-site)
Today, we're advancing programs in Endocrinology Rare Disease and Oncology.. Collaborate with Clinical Development, Pharmacovigilance, Biometrics, Core Team Members, Product Management, and Leadership teams to develop and implement the US and global regulatory affairs plan across products. Work closely with Commercial, Clinical Development, Medical Affairs, Pharmacovigilance, Biometrics, Core Team Members, Product Management, and Leadership teams in designing and implementing launch strategies and tactics, and life cycle planning with primary focus on the North and South American markets. Experience with biologics, CMC, Toxicology, Orphan Drugs development, breakthrough and fast track regulatory processes. Director, CMC Regulatory Affairs – Biologics
Abbott is a global healthcare leader, creating breakthrough science to improve people’s health.. Associate Director Regulatory Affairs – APAC. As a manager, the function of an Associate Director Regulatory Affairs, APAC (Asia Pacific) is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation.. + Approve regulatory filing strategies based upon proposed preclinical, clinical and manufacturing charges.. + Represent regulatory affairs in product recall and recall communication process in APAC.
Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases.. The Senior Manager/Associate Director of Clinical Quality Assurance Auditor is responsible for partnering with cross functional teams to manage the audit program and conducting audits (routine & for-cause clinical investigator site, vendor, CSR and internal audits).. Ensure compliance with applicable health authority regulations and guidelines for document management, TMF, and software used in GCP processes.. Quality Assurance Specialist, Financial Crimes. QA Analyst - Specialty Mental Health Compliance & Billing Specialist
Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases.. The Senior Manager/Associate Director of Clinical Quality Assurance Auditor is responsible for partnering with cross functional teams to manage the audit program and conducting audits (routine & for-cause clinical investigator site, vendor, CSR and internal audits).. Under the direction of the Executive Director of Clinical Quality Assurance, establish key processes and maintain the Nurix GCP QA audit program, policies, and procedures.. Ensure compliance with applicable health authority regulations and guidelines for document management, TMF, and software used in GCP processes.. Deep knowledge and understanding of drug development process, global regulations, and interfacing related to GXP, and GCP authorities
2+ years of previous sales experience in pharmaceuticals, biologics, or medical device sales required; 3+ years of sales experience in specialty pharmaceuticals preferred. Neuroscience Sales Specialist Base Salary range $100K - $150K. AI Training for Neuroscience (Freelance, Remote)Clinical Research Coordinator to Home-Based CRA (Clinical Research Associate). Associate Clinical Trials Management (Contract)Principal Clinical Research Associate – Shockwave Medical (Remote)Medical Affairs, Data Analyst (Healthcare & Scientific). Account Manager Oncology and Nuclear Medicine (Northern California)Account Executive (Merit Oncology) -Bay Area
Whether you're a clinical research associate (CRA), clinical trial coordinator, or involved in regulatory affairs, attending these conferences can significantly enhance your knowledge and skills.. Why Attend : Gain insights into the global regulatory landscape, including updates on the European Union’s Clinical Trials Regulation (CTR).. Key Focus : The summit will focus on clinical trial innovation, precision medicine, and adaptive trial designs.. Clinical Research Coordinator Certification. Clinical Research Associate (CRA) Certification
Carbon Health is looking for a physician with clinical research experience as a Principal Investigator to join a growing community of healthcare providers to deliver compassionate, evidence-based urgent care and conduct clinical trials in infectious disease and indications related to general medicine, including vaccine research and cardiometabolic health. Serve as a Principal Investigator for multiple clinical trials, Phases I to IV, where you will be responsible for the clinical research conduct and quality assurance, as well as supervising sub-investigators in their clinical trial work. Review and provide guidance on labs, diagnostic reports, diary reports, safety reports, and AEs/SAEs within a trial. Experience serving as a Principal Investigator on at least 3 prior randomized double-blinded therapeutic clinical trials. Hippo Education subscription, internal education resources and clinical rounds to support continuing medical education requirements.
Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.. As a Director, Early Oncology Global Regulatory Affairs, you will develop and execute Oncology regulatory strategies in alignment with the global regulatory strategies in collaboration with Franchise Lead and cross functional stakeholders in compliance with the appropriate regulations.. Extensive experience participating in cross-functional projects and teams with responsibilities related to clinical trials or other drug development activities.. Significant experience participating in cross-functional projects and teams with responsibilities related to clinical trials or other drug development activities.. BA/ BS or advanced degree in life sciences or related field with significant regulatory experience in the biopharma industry, regulatory agency, clinical research or other related healthcare environment.
Tanner and Associates is recruiting several Medical Directors of Oncology Clinical Research for major biotech companies located in San Francisco, Los Angeles, Salt Lake, and New Jersey.. Major biotech companies are seeking Medical Directors/Clinical Scientists with drug development experience to join their Oncology programs.. Candidates should have an M.D. with board certification or eligibility in hematology/oncology, or a PhD, PharmD with at least 5 years of drug development experience.. Develop initial clinical designs for future trials, collaborating with research, translational oncology, biostatistics, clinical operations, regulatory, and pharmacology teams, and presenting at Therapeutic Development Team meetings.. As Medical Monitor, oversee all aspects of key clinical trials in accordance with ICH/GCP guidelines.
The contract Biostatistician will be acting as an independent project-level statistician to support medical affairs/research, commercial, and safety. This role is responsible for statistical aspects of research questions, for coordinating the analysis, validation, and study documentation, and analyzing data for ad-hoc analyses (associated with pubs or adcomm prep) from all phases of studies. This position will work collaboratively with clinical development, pharmacology, clinical drug supply, project management, regulatory affairs, medical affairs, market access, safety, medical writing and data management, clinical operations, and especially with programming, and will sometimes collaborate with external statistics and programming vendors. Work closely with medical affairs, market access, pharmacovigilance, programming, and other biostatistician.. PhD degree in Statistics or Biostatistics with some applied statistics training relevant to the clinical trials or health research environment, and with 3 years of relevant work experience OR a Masters degree in Statistics or Biostatistics or a related health science field, and 5 years of biostatistical experience in the clinical trials or health research environment.
Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms.. IRI has built its reputation on excellent service and integrity since its inception in 1996.. CTMA -Late Phase plays vital role in successful implementation and support of important Collaborative (CO) and Investigator-Sponsored Research (ISR) projects.. Communicates and collaborates with other functional groups including but not limited to Medical Affairs, Regulatory Affairs, CCF, Materials and Logistics (M&L), and Drug Safety and Public Health (DSPH) to ensure efficient management of study activities.. Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of routine clinical trials, and ability to understand clinical study protocols a plus
Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need.. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need.. Experience working with one or more Gilead TAs and varying stages of drug development is strongly preferred.. As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce.