Lead CMC strategy and execution across clinical-stage therapeutic programs, ensuring regulatory alignment and manufacturing readiness.
Oversee external partnerships with CDMOs, consultants, and regulatory experts to deliver high-quality programs.
Manage CMC activities from due diligence through clinical development, balancing scientific rigor with operational speed.
The company is a partner organization in the biopharmaceutical industry, focusing on clinical-stage therapeutic programs. It operates in a high-growth, mission-driven environment with a culture of innovation and collaboration.
Analyze regulatory frameworks and licensing requirements across multiple jurisdictions.
Translate complex regulatory requests into structured compliance analyses and client deliverables.
Collaborate with engineering and legal teams to develop scalable compliance workflows and knowledge assets.
Our partner is a technology company focused on compliance and digital assets. They operate in a collaborative, international, and fully remote environment with a multidisciplinary team.
Develop and maintain clinical data listings, reports, and programming solutions to support data review and safety monitoring.
Analyze requirements from Data Management and Risk-Based Study Management teams and create efficient programming solutions.
Ensure all activities comply with regulatory requirements, industry guidelines, and internal procedures.
A partner company in the clinical research industry supports global clinical research programs through data analysis and programming. The company offers a fully remote, collaborative environment with a focus on continuous learning and improvement.
Provide regulatory advice and ensure compliance with U.S. regulations and ICH GCP guidelines for clinical research sites.
Coordinate IRB submissions, maintain regulatory documentation, and support site start-up and close-out activities.
Collaborate with cross-functional teams and monitor regulatory changes to advise stakeholders.
Care Access is working to make the future of health better for all by bringing world-class research and health services directly to communities that often face barriers to care. With hundreds of research locations, mobile clinics, and clinicians across the globe, the company is dedicated to ensuring every person has the opportunity to understand their health and contribute to medical breakthroughs.
Manage complex regulatory activities related to active pharmaceutical ingredients, including DIFA/DMF processes and lifecycle management.
Provide strategic guidance and risk management support for API documentation and supplier qualification.
Collaborate with multidisciplinary teams and external partners to ensure regulatory compliance and operational excellence.
The partner company is a player in the pharmaceutical industry, focusing on regulatory affairs and lifecycle management of innovative products. The team size and culture are not specified, but the role emphasizes collaboration, continuous improvement, and remote work based in Brazil.
Lead CMC regulatory activities for IND/CTA development and maintenance to support clinical trials and future MAA/NDA/BLA submissions.
Prepare and review CMC regulatory documents, assess changes, and collaborate cross-functionally to ensure compliance.
Represent regulatory on study teams and maintain knowledge of US and international regulations.
Erasca is a clinical-stage precision oncology company focused on discovering, developing and commercializing medicines for cancer patients. The company targets the RAS/MAPK pathway and fosters a collaborative, mission-driven culture.
Responsible for submission planning and management of IND-related activities, including annual reports, DSURs, and CTA activities.
Manages the compilation, QC, and submission of INDs, BLAs, and amendments, and prepares routine regulatory documents.
Represents Regulatory Affairs on cross-functional teams, providing expertise and managing submission trackers.
Iovance Biotherapeutics is a biotechnology company pioneering tumor infiltrating lymphocyte (TIL) therapy for cancer. It is a small, fast-paced company with a collaborative and innovative culture.
Manage day-to-day regulatory affairs support, including clinical trial applications and compliance with global regulations.
Provide expert guidance to project stakeholders, ensuring timely and high-quality service delivery.
Develop regulatory strategies and tools, staying current with industry best practices and regulatory changes.
Alimentiv provides global regulatory affairs support services for clinical research. The company emphasizes high-quality service delivery, compliance with industry standards, and a collaborative culture.
Support validation and documentation activities for global EDC systems and clinical study operations.
Execute validation test scripts and document results in line with regulatory guidelines.
Maintain validation metrics and assist in reporting for process transparency and performance tracking.
The company partners with global clinical research organizations to support validation and compliance operations. It functions as a mission-driven organization focused on healthcare innovation, operating within a structured, regulated environment.
Develop and implement global CMC regulatory strategies for biologic and combination products.
Prepare and manage CMC submissions, briefing documents, and health authority meeting packages.
Serve as the CMC Regulatory lead on cross-functional project teams and support health authority interactions.
Jade Biosciences is a clinical-stage biotechnology company focused on developing best-in-class therapies for autoimmune diseases. The company is a small, dynamic organization with a collaborative culture and a strong focus on regulatory excellence.
Lead CMC regulatory strategy for small molecule drugs in global Phase 1-3 trials.
Write and manage investigational regulatory submissions for US, EU, and ROW.
Support risk mitigation and GMP compliance across development programs.
Recursion is a clinical-stage TechBio company decoding biology to radically improve lives. The company employs a global team and fosters a culture of bold action, care, and collaboration.
Provide strategic leadership and functional representation for complex projects, ensuring effective coordination and execution of regulatory tasks.
Act as a franchise liaison between Ergomed Plc and clients, assisting in securing new business by participating in bid defenses and contributing to proposals and budgets.
Offer expert regulatory guidance, training, and mentoring to junior staff, while driving department initiatives and managing change implementation.
PrimeVigilance is a global pharmacovigilance specialist that helps clients navigate complex regulations while keeping patient safety at the center of every decision. With a presence across Europe, North America, South America, Asia, and Australia, the company fosters a culture built on kindness, flexibility, growth, and belonging.
Oversee clinical site management and ensure compliance with protocols, regulations, and quality standards.
Serve as primary contact for study sites, conducting monitoring visits from pre-study through close-out.
Collaborate with cross-functional teams to support data review, regulatory submissions, and site performance.
Our partner is a global clinical research organization managing monitoring activities across Phase I–IV trials and Real World Evidence studies. It offers a collaborative, fully remote environment focused on improving patient outcomes with professional growth opportunities.
Provide strategic regulatory input and manage European Clinical Trial Applications (CTA) and amendments.
Serve as key regulatory liaison for multi-continental oncology projects, collaborating with cross-functional teams.
Maintain expertise in GCP, EU regulations, and support business development activities.
Theradex Oncology is a full-service CRO specializing in early and late-phase oncology trials globally. Founded in 1982 with over 40 years of experience, the company has managed more than 250 trials and partners with the National Cancer Institute, maintaining a focused culture on cancer drug development.
Coordinate and track international regulatory submissions for IVD products in the EMEA region.
Manage regulatory release of products using the GTS tool and ensure compliance with IVD/medical device regulations.
Collaborate with global teams to document regulatory assessments and oversee channel partner licenses and renewals.
Agilent provides life science, diagnostic and applied market laboratories with instruments, services, consumables, applications and expertise. With 18,000 employees worldwide, the company fosters a culture of trust, respect, integrity, and inclusivity.
Coordinate recruitment delivery operations and maintain accurate client requirements and trackers.
Work closely with recruiters and clients to ensure timely candidate delivery and interview scheduling.
Support process improvements and maintain operational visibility across international teams.
They specialize in technology recruitment, coordinating recruitment operations for global clients. They are a fast-growing organization with a supportive and collaborative remote work culture.
Provide study oversight as primary liaison between CRAs, internal staff, site staff, client personnel, and external vendors.
Ensure clinical monitoring activities comply with SOPs, regulations, GCP, KPIs, and study-specific requirements.
Develop and manage clinical plans and guidelines, including the clinical monitoring plan and study timelines.
ProTrials is a women-owned, WBENC-certified Contract Research Organization (CRO) that has been a trusted partner in clinical research since 1996, supporting research behind innovative treatments in pharmaceutical, biotech, and medical device industries. They foster a collaborative community where team members feel valued, supported, and empowered to make a meaningful impact on global health.
Act as the primary point of contact for clients, ensuring timely and accurate delivery of legal entity management services.
Maintain accurate records, monitor legal compliance, and coordinate with internal teams and external service providers.
Develop client relationships, provide guidance on best practices, and support the development of new services.
HSP Group is the premier provider of global expansion services, helping companies simplify international operations. With a focus on scale-up organizations and innovative technology firms, HSP is positioned as a trusted global partner, offering a comprehensive suite of services across legal entity setup, HR, payroll, compliance, tax, and advisory.
Coordinate day-to-day clinical trial operations remotely, ensuring compliance with protocols and regulations.
Support remote patient visits including scheduling, documentation, and follow-up.
Maintain accurate data entry in EDC/CTMS systems and assist with regulatory documentation.
UniTriTeam is a global leader in providing operational, administrative, and technology support to clinical research sites. They have a mission-driven, supportive, and inclusive team culture.