Regulatory Affairs Bio Manager

Boehringer Ingelheim GmbH; Spring Valley Estates (GA); On-site; USD 150,000 - 210,000; Full time

Job summary

Boehringer Ingelheim USA seeks a Manager, Regulatory Affairs Bio to oversee regulatory submissions and compliance for veterinary biologics regulated by the USDA across multiple facilities. This role provides strategic regulatory input to Manufacturing, R&D, Commercial Operations, and Supply Chain in cross-functional teams supporting licensed products.

Responsibilities include maintaining regulatory dossiers, guiding health authority interactions, and ensuring inspection readiness while staying

Qualifications

• Must be legally authorized to work in the United States without restriction.
• Willing to take a drug test and post-offer physical (if required).
• Must be 18 years of age or older.
• Leads regulatory projects and cross-functional teams across global registrations.
• Fluent in English.

Responsibilities

• Prepare, review, and oversight of regulatory submissions to health authorities.
• Define worldwide regulatory requirements and strategy for new registrations and lifecycle management.
• Maintain regulatory archives and information management systems.
• Provide regulatory guidance to manufacturing, R&D, and commercial teams.
• Lead stakeholder interactions with federal/state authorities and inspections.

Skills

Regulatory strategy

Regulatory submissions

Leadership

Regulatory affairs

English proficiency

Education

DVM or PhD in biomedical sciences

Master’s degree in biomedical sciences

Bachelor’s degree in biomedical sciences

10 years related regulatory experience (in lieu of degree)

Tools

BIRDS

DAVID

Idea for Con

Job description

Boehringer Ingelheim USA seeks a Manager, Regulatory Affairs Bio to oversee regulatory submissions and compliance for veterinary biologics regulated by the USDA across multiple facilities. This role provides strategic regulatory input to Manufacturing, R&D, Commercial Operations, and Supply Chain in cross-functional teams supporting licensed products.

Responsibilities include maintaining regulatory dossiers, guiding health authority interactions, and ensuring inspection readiness while staying