Regulatory Affairs Pharmacovigilance Manager

Jobgether · US

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.

Accountabilities:

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.

Requirements:

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.

Benefits:

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.

Healthcare pay context

Based on 3,206 disclosed Healthcare salaries on RoleSuite, the role pays a median of $114K/year, with most offers between $87K and $166K (10th–90th percentile: $66K–$247K).

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Regulatory Affairs Pharmacovigilance Manager

Accountabilities:

Requirements:

Benefits:

Healthcare pay context

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