Lead global regulatory strategy for one or more drug development programs, with emphasis on submissions and health authority interactions.
Plan, manage, and create Clinical Trial Applications, Market Applications, and amendments, ensuring high-quality documents.
Collaborate with cross-functional teams to create and negotiate clinical-regulatory development paths and prepare for health authority meetings.
Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. They are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.
Ensure product claims, labeling, and regulatory documentation meet FDA and FTC requirements for dietary supplements.
Work cross-functionally with Brand, Product, Quality, and Marketing teams to translate regulatory frameworks into actionable guidance.
Support GMP compliance, audits, and process improvements to strengthen regulatory operations at scale.
The company is a partner organization managing applications and next steps for a role in consumer health. They are a science-led organization with a growing portfolio of microbiome and nutrition-focused innovations.
Oversee Trial Master File (TMF) activities including document review, quality checks, and study-level engagement to ensure regulatory compliance.
Manage a team of Documents Specialists, Quality Review Specialists, and TMF Leads, providing training, performance management, and support.
Collaborate with leadership to drive process improvements and ensure efficient records management across clinical programs.
Precision Medicine Group is a contract research organization providing clinical research services. The company is expanding across Latin America and fosters a collaborative, quality-focused culture.
Ensure timely review, processing, and quality of Trial Master Files (TMF) according to GCP and SOPs.
Create and execute study TMF plans, manage document indexing, and communicate changes to project teams.
Monitor TMF health, identify risks, and support audits and inspections for compliance.
Precision Medicine Group is a global contract research organization providing clinical trial support and precision medicine services. The company values professionalism, collaboration, and quality, with a focus on maintaining inspection-ready trial master files.
Define and execute global regulatory strategies across early- and late-stage development for small molecules and combination products.
Lead and oversee interactions with FDA, EMA, and other global regulatory agencies.
Author, review, and submit key regulatory documents, including INDs, CTAs, briefing books, and response packages.
Enveda reinvents drug discovery by harnessing nature's intelligence, identifying new medicines four times faster than the industry standard. The company achieved unicorn status after a $150M Series D in 2025, has an award-winning culture recognized by Newsweek and Forbes, and values creativity, collaboration, and deep respect for each team member.
Lead and manage the clinical operations team, setting and executing departmental strategy.
Oversee clinical trial agreements, budgets, expenditures, and ensure timely execution of clinical programs.
Establish and maintain good working relationships with clinical study site personnel and oversee study conduct.
Iovance Biotherapeutics is a biotechnology company focused on developing tumor infiltrating lymphocyte (TIL) therapy for cancer. The company is pioneering a transformational approach to treating cancer and is committed to continuous innovation in cell therapy, including gene-edited cell therapy.
Develop and evolve a clinical governance framework adaptable across markets, including policies, standards, and oversight structures.
Design quality monitoring programs and track key clinical quality metrics to ensure consistent, safe telehealth services.
Partner with regional teams on regulatory compliance, risk mitigation, and continuous improvement initiatives.
HeliosX is a healthcare platform that makes healthcare faster and more accessible, operating proprietary brands like MedExpress and Dermatica with vertical integration. With over 1.7 million patients treated in 2025 and £781m in revenue, we are a fast-growing, profitable company with a culture of discipline and clinical excellence.
Serve as primary contact for assigned study sites, ensuring protocol implementation and compliance with ICH-GCP and local regulations.
Conduct on-site and remote monitoring visits, building strong relationships with site staff and resolving operational issues.
Maintain inspection readiness of sites, manage study documentation, and contribute to study performance tracking and recruitment support.
Our partner is a clinical research organization that manages global clinical trials. They offer a collaborative global team environment and opportunities for career development in clinical operations.
Lead batch release activities and provide GMP oversight for manufacturing partners to ensure compliance with global regulations.
Manage investigations, deviations, CAPA, and change controls while supporting audits and inspections.
Mentor and develop junior QA staff and contribute to quality system improvements.
Deciphera is a biopharmaceutical company dedicated to developing innovative therapies for cancer. The company fosters a collaborative culture with opportunities for personal and professional growth.
Provide subject matter expertise to teams for global disclosure strategies of clinical documents under regulatory requirements.
Manage planning, preparation, and quality control for disclosures, including oversight of vendor deliverables.
Lead development of standard processes and technological solutions to ensure compliance with disclosure regulations.
Pfizer is a global biopharmaceutical company dedicated to discovering and developing innovative therapies. As a large multinational employer with a culture of individual ownership, it employs tens of thousands of people and fosters a collaborative and inclusive environment.