Define and lead global regulatory strategy for clinical-stage radiopharmaceutical programs.
Lead key regulatory submissions including INDs, CTAs, and DMFs.
Serve as primary contact for regulatory agencies and build strong relationships with health authorities.
ARTBIO discovers and develops a new class of Alpha Radioligand Therapies (ARTs) to redefine cancer care. It is a global biotech with offices in Boston, Basel, London, and Oslo, fostering a collaborative and supportive culture.
Provide regulatory strategy and guidance across the clinical development lifecycle, including submissions to Regulatory Authorities and Ethics Committees.
Coordinate and prepare regulatory documents such as CTA/IND, annual reports, amendments, orphan designations, and marketing applications.
Represent Global Regulatory Affairs at project team meetings, lead submission projects, and mentor Regulatory Affairs Specialists.
Precision for Medicine is a CRO that integrates clinical trial execution with deep scientific knowledge, laboratory expertise, and advanced data sciences, focusing on Oncology and Rare Disease. They are a growing global team that values employee contributions and fosters an environment where ideas are valued and nurtured.
Support the development and execution of clinical regulatory strategies for assigned programs across regions.
Prepare and manage IND applications and other regulatory submissions, ensuring accuracy and timely delivery.
Provide regulatory guidance to cross-functional teams and participate in health authority interactions.
Zai Lab is an innovative, research-based biopharmaceutical company based in China and the US, focused on bringing transformative medicines for oncology, autoimmune disorders, infectious diseases, and neurological disorders to patients worldwide. Founded in 2014, Zai Lab has a global team of approximately 2000 employees and is committed to gender diversity and environmental responsibility.
Review CMC sections of regulatory submissions for drug-device combination products, ensuring accuracy and alignment with global requirements.
Contribute to global regulatory CMC strategies and provide guidance to cross-functional stakeholders.
Collaborate with device development, quality, clinical, human factors, and other teams to support product compliance and change controls.
The company specializes in drug-device combination products and operates in a cross-functional, science-driven environment. The culture emphasizes collaboration across regulatory, device development, quality, clinical, and human factors teams.
Own regulatory review and approval of promotional materials across HCP, DTC, digital, and social channels, ensuring compliance with FDA regulations.
Partner with Commercial, Medical Affairs, and Legal to shape campaigns and claims, providing clear guidance to reduce approval delays.
Lead FDA promotional submissions, monitor regulatory trends, and build scalable processes to support product launches.
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders. The company values Trust, Ownership, Curiosity, and Results, and offers a collaborative, high-achieving environment with a focus on diversity and inclusion.
Develop and lead integrated global regulatory strategies for I&I pipeline programs.
Serve as primary regulatory strategist and Health Authority relationship lead.
Provide expert guidance on development plan design and filing strategies.
Beeline Medicines is a clinical-stage biotechnology company developing precision therapies for autoimmune and inflammatory diseases. It is a small company backed by world-class investors, with a culture of scientific rigor and operational excellence.
Develop Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs) per EU MDR to support CE Mark submissions.
Interact with cross-functional teams to define strategies for clinical documentation and regulatory submissions.
Conduct literature searches, critically appraise scientific data, and write clinical summaries for products and surgical procedures.
Intuitive is a global leader in robotic-assisted surgery and minimally invasive care, developing technologies like the da Vinci surgical system and Ion to transform surgery. The company is a team of engineers, clinicians, and innovators united by a purpose to make surgery smarter, safer, and more human, with challenging but deeply meaningful work.
Creates and executes the study TMF Plan and ensures team understanding of expectations.
Monitors and reports on TMF Health to internal team and sponsor, identifying trends and risks.
Serves as point of contact for audits and inspections, and supports process improvement initiatives.
Precision for Medicine is a clinical research organization that provides services for drug development, including trial management and regulatory compliance. The company fosters a collaborative environment with a focus on quality and innovation.
Responsible for site activation readiness, submission preparation, and interaction with Competent Authorities and Ethics Committees.
Manage essential document collection, informed consent customization, and maintain project plans and trackers.
Partner with cross-functional teams and act as subject matter expert for country-specific regulatory knowledge.
We are a global life sciences company specializing in clinical trial regulatory and start-up services. We are expanding our capabilities across Latin America and seek experienced professionals to join our team.
Lead disease awareness and relationship development with key experts for EBV+ PTLD in preapproval phase.
Drive demand and support treatment experience of Tab-cel post-approval within assigned territory.
Navigate complex accounts, collaborate cross-functionally, and create strategic account plans.
Pierre Fabre is a private French multinational pharmaceutical and dermo-cosmetics company. It is one of the world's largest dermo-cosmetics companies and a leading European pharmaceutical laboratory, recognized by Forbes as a top employer.
Lead author on complex regulatory and clinical documents including protocols, CSRs, IBs, and IND/NDA/BLA submissions.
Provide strategic input on document planning, messaging, and quality control while mentoring other writers.
Manage multiple projects independently, balancing timelines and client expectations in a fully remote environment.
Eldridge Writing provides top-tier medical writing services to pharmaceutical and biotechnology clients. We are a small, collaborative team that values quality and serves as a true extension of our clients’ teams.
Support Clinical Trial Managers with study start-up, protocol development, and Trial Master File preparation.
Coordinate with clinical sites on documentation, training, and compliance with FDA and GCP requirements.
Assist with tracking study payments and providing operational support across the full study lifecycle.
The company is a partner organization specializing in clinical research and development, operating through Jobgether. It offers a structured clinical operations environment with cross-functional teams and professional growth opportunities.
Provide regulatory affairs support for FDA medical device compliance, including pre-market submissions (510(k), PMA), post-market surveillance, and quality system audits.
Collaborate cross-functionally with R&D, Quality Assurance, and Sales to ensure compliance with U.S. FDA and international regulations (ISO 13485, MDSAP, EU MDR).
Perform regulatory documentation and submissions for new products and changes, and handle customer complaints, field actions, and risk assessments.
FUJIFILM Healthcare Americas Corporation provides cutting-edge healthcare solutions spanning diagnostic imaging, enterprise imaging, endoscopic and surgical imaging, and in-vitro diagnostics. The company is part of Fujifilm, which has over 70,000 employees globally and fosters a dynamic, flexible environment focused on innovation and collaboration.
Monitor clinical trial sites to ensure compliance with protocols, SOPs, and regulatory requirements.
Review electronic medical records and source documentation for accuracy and data integrity.
Support site staff and contribute to development of trial materials, SOPs, and training guides.
Orca Bio is a commercial-stage biotechnology company developing next-generation cell therapies to improve transplant outcomes for blood cancer patients. The company maintains a start-up culture with an entrepreneurial spirit and emphasis on camaraderie.
Drives strategic growth by generating high-value partnerships for the proprietary AJIPHASE® platform.
Coordinates technical project management and CMC alignment between North American clients and manufacturing teams in Japan.
Negotiates and structures MSAs and SOWs to secure new clinical and commercial API pipelines.
Ajinomoto Co., Inc. is a global leader in amino acid science, biotechnology, and healthcare, with an expanding presence in biopharmaceutical contract manufacturing. Forge Biologics, its U.S. subsidiary, brings proprietary Japanese biomanufacturing technologies to the North American market, with a focus on innovative oligonucleotide and peptide synthesis.
Lead safety evaluations and benefit-risk assessments for assigned products.
Provide medical leadership for pharmacovigilance activities across development and marketed products.
Support regulatory submissions and health authority interactions, including preparing responses to RFIs.
Alphanumeric is a staffing and recruiting company that places professionals in contract roles with top organizations. This role is a 1-year contract with a major pharmaceutical company, supporting its global Safety Evaluation & Risk Management function.
Lead QMS and regulatory remediation to align global procedures with FDA QMSR and ISO 13485.
Manage global regulatory submissions and interactions with Notified Bodies for EU MDR, UKCA, and other markets.
Serve as RA representative on core project teams for hardware and AI/software releases.
Eko Health develops AI-powered digital stethoscopes and ECG tools to help clinicians detect heart and lung disease. The company is venture-backed, recognized by TIME as a top healthtech company, and has a mission-driven team of engineers, physicians, and creatives.
Serve as the primary point of contact for assigned protocols, linking Country Operations with the clinical trial team.
Manage project timelines, deliverables, and performance for clinical studies from feasibility to close out.
Ensure compliance with ICH/GCP, country regulations, and company policies while leading local study teams.
Merck is a global healthcare leader with a diverse range of prescription medicines, vaccines, and animal health products. With over 100 years of history, the company employs tens of thousands worldwide and fosters a culture of innovation and inclusivity.
Manage regulatory submissions and site activation for clinical trials in Spain, ensuring compliance and timelines.
Negotiate site contracts and budgets, and coordinate with Competent Authorities and Ethics Committees.
Maintain project trackers, oversee essential documents, and support translation activities for patient materials.
Precision for Medicine is a global Clinical Research Organization specializing in precision medicine, combining novel trial designs, biomarkers, and data analytics. They focus strongly on rare diseases and oncology, and their culture emphasizes innovation, collaboration, and regulatory excellence.