Regulatory Affairs Manager (Expanded Access Programs) in United States at Jobgether
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Job Description
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Regulatory Affairs Manager (Expanded Access Programs) based in United States.
This is a high-impact regulatory role at the intersection of global drug access, clinical innovation, and patient-centered healthcare. You will play a key part in enabling Expanded Access Programs (EAPs) that help patients receive potentially life-saving treatments outside of clinical trials. The role focuses on ensuring full regulatory and pharmacovigilance compliance across multiple countries while supporting the operational execution of access programs. You will collaborate closely with Medical Affairs, Quality, Supply Chain, and external biopharma partners in a highly cross-functional environment. A strong emphasis is placed on translating complex global regulations into practical execution frameworks that scale. You will also contribute to building and strengthening the regulatory infrastructure that supports a rapidly growing global health tech organization. This is a mission-driven role where regulatory expertise directly impacts patient access to innovative therapies.
- Support the development and execution of regulatory strategies for Expanded Access Programs (EAPs) involving biologics, cell therapies, and small molecule therapies across global markets.
- Act as a regulatory affairs and pharmacovigilance subject matter expert in communications with pharmaceutical clients, health authorities, and cross-functional internal teams.
- Prepare, compile, and submit regulatory dossiers for cohort and named-patient EAPs in compliance with applicable global regulations.
- Contribute to the design and refinement of regulatory strategies for launching and managing EAPs, including geographic and operational planning.
- Ensure timely, accurate, and compliant execution of all regulatory and pharmacovigilance activities across active programs.
- Collaborate with Commercial, Medical Affairs, Quality Assurance, and Supply Chain teams to support the successful setup and execution of EAPs.
- Maintain up-to-date knowledge of global regulatory frameworks governing expanded access and translate updates into internal guidance and processes.
- Support the creation, review, and maintenance of regulatory documentation, SOPs, templates, and compliance materials.
- Liaise with pharmacovigilance vendors to ensure alignment, oversight, and adherence to global safety reporting requirements.
- Contribute to quality systems activities including documentation control, quality incidents, and corrective and preventive actions (CAPAs).
- ~5 years of experience in Regulatory Affairs, including direct exposure to Expanded Access Programs or similar early access frameworks.
- Solid understanding of pharmacovigilance principles and global safety reporting requirements.
- Strong knowledge of international and national regulations related to Expanded Access, compassionate use, or named-patient programs.
- Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or a related scientific discipline.
- Experience working with external stakeholders, including pharmaceutical clients, health authorities, or clinical partners.
- Strong written and verbal communication skills in English, with the ability to explain complex regulatory topics clearly; additional languages are a plus.
- Proactive and solution-oriented mindset with the ability to anticipate regulatory risks and propose practical mitigations.
- Comfortable working in a fast-paced, cross-functional, and international environment.
- Familiarity with Microsoft 365 tools (Word, Excel, Teams, SharePoint) and collaborative documentation workflows.
- Competitive salary with annual performance bonus and employee stock option plan
- Fully remote or hybrid-friendly international working environment (depending on location)
- Meaningful, mission-driven work improving access to potentially life-saving treatments
- Strong career development opportunities within a fast-growing global organization
- Learning and development budget plus internal knowledge-sharing initiatives
- Policies supporting work-life balance and working parents
- Access to mental well-being support, including professional psychological guidance
- Inclusive culture with global team events and community-driven initiatives
- Dynamic scale-up environment with high autonomy and cross-functional collaboration.