Regulatory Affairs Pharmacovigilance Manager in United States at Jobgether
NewJob Function: Information Technology
Jobgether
United States, United States
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Job Description
Regulatory Affairs Pharmacovigilance Manager
Accountabilities:
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 & Pharmacovigilance Manager based in the United States.
This role sits at the intersection of regulatory strategy and patient access, ensuring that Expanded Access Programs (EAPs) are executed in full compliance with global regulatory and pharmacovigilance requirements. You will play a key part in enabling access to innovative therapies by supporting submissions, maintaining regulatory integrity, and guiding cross-functional execution across complex international programs. The environment is highly collaborative and mission-driven, bringing together regulatory, medical, quality, and supply chain experts. You will act as a key subject matter expert in interactions with pharmaceutical clients and health authorities. The role requires strong regulatory judgment, attention to detail, and the ability to navigate evolving global legislation. It is ideal for someone who thrives in a fast-paced, purpose-led setting focused on patient impact.
- Lead and support regulatory strategy development for Expanded Access Programs (EAPs), including programs involving biologics, cell and gene therapies, and synthetic drugs.
- Serve as a regulatory and pharmacovigilance subject matter expert in client communications, health authority interactions, audits, and cross-functional project meetings.
- Prepare, compile, and submit complete regulatory dossiers for both cohort-based and named-patient EAPs on behalf of clients.
- Contribute to the design and execution of regulatory approaches for EAP setup, including geographic and operational considerations.
- Ensure timely, accurate, and compliant execution of all regulatory and pharmacovigilance activities related to EAP operations.
- Collaborate closely with Medical Affairs, Quality Assurance, Program Management, Supply Chain, and Commercial teams to ensure seamless program delivery.
- Maintain up-to-date knowledge of global regulations and guidelines impacting Expanded Access and ensure internal alignment with evolving requirements.
- Support the development, review, and maintenance of regulatory documentation, templates, SOPs, CAPAs, and quality systems.
- Liaise with pharmacovigilance service providers to ensure end-to-end compliance and alignment of safety reporting processes.
- Approximately 5 years of experience in Regulatory Affairs, with direct exposure to Expanded Access Programs strongly preferred.
- Solid foundational knowledge of Pharmacovigilance principles and global safety reporting requirements.
- Strong understanding of national and international regulations governing Expanded Access and related regulatory frameworks.
- Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Medicine, or a related scientific discipline.
- Proven experience working with external stakeholders, including pharmaceutical clients or regulatory authorities.
- Excellent written and verbal communication skills in English, with the ability to translate complex regulatory concepts into clear guidance.
- Strong collaboration skills and ability to work effectively in cross-functional, international environments.
- Proactive, solution-oriented mindset with the ability to anticipate regulatory risks and propose practical solutions.
- Proficiency with Microsoft 365 tools (Word, Excel, Teams, SharePoint) and comfort working in digital, process-driven environments.
- Competitive salary with annual performance-based bonus
- Employee Stock Option Plan (ESOP)
- Learning and development budget and continuous internal knowledge-sharing opportunities
- Hybrid working flexibility (for eligible regions) and support for work-life balance
- Policies supporting working parents and caregivers
- Access to confidential mental health and psychological support services
- International, mission-driven work environment focused on improving patient access to therapies
- Regular team events, culture initiatives, and company-wide celebrations
- Opportunity to contribute directly to impactful work enabling access to potentially life-saving treatments
- Career growth opportunities within a fast-scaling global organization.
How Jobgether works:
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.
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Job Location
United States, United States
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