Develop and maintain integrated project plans for global regulatory submissions, ensuring adherence to scope, timelines, budgets, and quality standards.
Act as the primary regulatory timeline contact across Clinical, Nonclinical, CMC, Quality, and Commercial functions, fostering collaboration and alignment.
Identify and mitigate project risks, prepare teams for agency meetings, and lead responses to regulatory queries from global health authorities.
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.
Serve as primary author and lead reviewer for CMC sections of late-stage and commercial regulatory submissions.
Provide hands-on CMC regulatory expertise across global filings, health authority interactions, and post-approval activities.
Collaborate with cross-functional teams to align regulatory strategy with scientific and compliance requirements.
The company is a biotechnology organization developing innovative cell therapies for late-stage and commercial stages. It offers a collaborative, entrepreneurial, and innovative work environment with a fast-paced, senior-level team.
Lead U.S. and global regulatory strategies for oncology biologic development programs.
Prepare and manage Clinical Trial Applications, Marketing Applications, and regulatory amendments.
Collaborate with cross-functional teams to align regulatory plans and manage program risks.
A partner company is seeking a strategic regulatory affairs leader to support innovative oncology biologic and cell/gene therapy development programs. The company offers a fully remote environment with global regulatory exposure and cross-functional collaboration.
Lead regulatory strategy for oncology drug development programs, ensuring alignment with US and global health authorities.
Plan and manage Clinical Trial Applications, Market Applications, and amendments with high-quality submissions.
Collaborate cross-functionally to integrate evolving regulations and drive process improvements.
Iovance Biotherapeutics is a global leader in developing and delivering tumor infiltrating lymphocyte (TIL) cell therapies for solid tumors, with an FDA-approved treatment for advanced melanoma. The company operates as an end-to-end cell therapy organization with U.S.-based manufacturing, serving thousands of cancer patients worldwide.
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.
Lead regulatory and PV deliverables for complex projects, ensuring compliance and timely execution.
Provide strategic regulatory guidance and support business development through proposals and budgets.
Mentor and train junior staff, prepare invoices, and ensure audit readiness.
PrimeVigilance is a global pharmacovigilance specialist helping clients navigate complex regulations while keeping patient safety at the center of every decision. With teams across Europe, North America, South America, Asia, and Australia, we foster a culture built on kindness, flexibility, growth, and belonging.
Implement projects ensuring client deliverables quality and profitability.
Coordinate cross-functional brand teams and facilitate medical, legal, regulatory reviews.
Maintain client contact and assist with financial reporting and budget monitoring.
This agency specializes in market access marketing communications for the pharmaceutical and life sciences industry. It fosters a fast-paced, collaborative environment with opportunities for professional growth.
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.
Lead Loyal's overall regulatory strategy across CMC and clinical activities, from early development through post-approval lifecycle management.
Act as the primary liaison with global regulatory agencies and own approval submission strategy and execution.
Build and scale a high-performing regulatory organization, establishing governance frameworks and eCTD publishing capabilities.
Loyal is a clinical stage veterinary medicine company developing longevity drugs for dogs. It is a well-funded startup led by a first gen female CEO, with a culture focused on innovation, transparency, and empathy for all life.
Provides administrative and project support for quality assurance and program activities.
Coordinates project logistics, documentation, procurement, and compliance processes.
Maintains records, tracks deliverables, and supports audit-ready documentation across workstreams.
This organization is dedicated to international development and quality assurance programs. It fosters a collaborative, mission-driven culture with a focus on inclusion and professional growth.
Lead end-to-end labeling activities across the product lifecycle for pre- and post-market products.
Guide global labeling strategy, document development, and cross-functional regulatory teams.
Provide strategic labeling expertise to support safe and effective product use and regulatory compliance.
A global regulatory affairs organization focused on pharmaceutical product labeling. It provides a collaborative, science-driven environment with cross-functional and international exposure.
Serve as primary point-of-contact liaison with clients, providing outstanding customer service and participating in proposal activities and client presentations.
Oversee all aspects of clinical research trials, directing project managers and ensuring consistency across assigned portfolios.
Manage study budgets, financial health, and project plans, including risk management and quality assurance, while leading cross-functional teams.
Precision Medicine Group is a people-focused CRO that combines novel clinical trial designs, industry-leading operational and medical authorities, and advanced biomarker and data analytics solutions, with a passion for rare diseases and oncology. The company fosters a supportive and collaborative environment, promoting work-life balance and team development, with a growing team dedicated to ground-breaking cancer therapies.
Build trust with state healthcare regulatory boards and agencies to drive growth of the CE Broker solution.
Serve as the primary point of contact for assigned state partners, guiding operational efficiency and compliance.
Navigate multi-year government decision cycles with a consultative, relationship-first approach.
Propelus simplifies workforce compliance management across healthcare, providing technology and strategic partnerships that empower professionals, employers, and regulators. A trusted leader for over 20 years, the company serves millions with seamless compliance solutions and has been named a BuiltIn 2025 Best Places to Work.
Manage client relationships and serve as lead point of contact for assigned projects.
Oversee project implementation, quality control, and coordination with internal teams.
Facilitate medical-legal-regulatory review processes and ensure compliance.
Precision AQ is the top payer marketing agency that partners with global pharmaceutical and life sciences companies to make medicines accessible and affordable. The company recognizes achievements, offers mentorship opportunities, and promotes cross-functional teamwork in a supportive culture.
Own the digital product vision, strategy, and roadmap for Medical Affairs and Evidence Generation platforms.
Bridge medical and technical stakeholders to translate complex scientific needs into actionable requirements.
Ensure compliance with regulations and enable data-driven decision-making through digital tools.
Our partner is a global digital technology organization in the life sciences sector. They offer a collaborative, multicultural environment focused on innovation and cross-functional partnership.
Manage designated Medicaid, EQR, compliance, and quality improvement projects through all stages from planning to completion.
Coordinate with internal teams, external partners, and stakeholders to ensure project milestones and deliverables are met.
Prepare reports, workplans, and presentations while monitoring project progress and identifying risks.
Health Services Advisory Group (HSAG) is a healthcare organization dedicated to improving the quality of healthcare delivery. The company is a growing team that transforms healthcare in the United States, fostering a culture of community and fun.
Lead Medical Affairs workstreams including KTL engagement, congress activities, and scientific communications.
Develop and execute strategic medical plans, translating scientific evidence into actionable recommendations.
Provide scientific expertise across the product lifecycle, supporting clinical education and evidence communication.
Kaléo is a pharmaceutical company focused on developing life-saving auto-injector devices for patients. They are a lean, cross-functional organization with a passionate, purpose-driven culture and a highly collaborative, close-knit team.
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.
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.
Develops and drives regulatory strategy for FDA Pharma and IVDR initiatives.
Represents the regulatory function on cross-functional teams and interacts with regulatory authorities.
Coordinates regulatory submissions and ensures compliance with global requirements.
Natera is a clinical genetic testing company specializing in non-invasive cell-free DNA and liquid biopsy testing. The team consists of highly dedicated professionals from world-class institutions who care deeply for their work and each other.