US Regulatory Affairs Manager - Safety & Efficacy

Boehringer Ingelheim; Athens (GA); Hybride; USD 120 000 - 180 000; Plein temps

Résumé du poste

Boehringer Ingelheim Animal Health USA seeks a Manager, RA Pharma Safety & Efficacy to lead US regulatory safety and efficacy and drive strategy for development projects. You will handle FDA meetings and submissions, link regulatory data to stakeholders, and ensure timelines and approvals in a global development context.

The role requires expertise in regulatory affairs, strong communication, and the ability to collaborate across a global organization while managing multiple projects.

Qualifications

• Advanced degree in life sciences with regulatory experience in pharma/biotech.
• Experience in regulatory affairs or pharma industry compliance.
• Strong English written and verbal communication skills.

Responsabilités

• Own safety and efficacy dossier components for US-dedicated products.
• Coordinate inputs for FDA submissions and labeling.
• Work in project teams to drive Target Product Profile objectives.
• Provide regulatory advice on pathways, timelines, and costs for approvals.
• Represent BI at external meetings and governance reviews.
• Support regulatory due diligence and dossier evaluations.

Connaissances

Regulatory affairs

FDA submissions

Cross-functional collaboration

Regulatory strategy

Life sciences

Formation

DVM or PhD in relevant discipline

Master's degree in relevant scientific discipline

Description du poste

Boehringer Ingelheim Animal Health USA seeks a Manager, RA Pharma Safety & Efficacy to lead US regulatory safety and efficacy and drive strategy for development projects. You will handle FDA meetings and submissions, link regulatory data to stakeholders, and ensure timelines and approvals in a global development context.

The role requires expertise in regulatory affairs, strong communication, and the ability to collaborate across a global organization while managing multiple projects.