Regulatory Affairs Pharmacovigilance Manager
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 & 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.
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.