Regulatory Affairs Bio Manager - Veterinary Biologics

Boehringer Ingelheim GmbH; Northern (KY); Hybrid; USD 120,000 - 180,000; Full time

Benefits offered by this job

Global collaboration opportunities

Travel up to 10%

Job summary

Boehringer Ingelheim USA seeks a senior regulatory affairs leader to manage submissions for new product registrations, lifecycle management, and compliance for veterinary biologics regulated by USDA. The role involves coordinating with R&D, manufacturing, and quality teams, and representing the company in health authority interactions.

The incumbent will oversee regulatory archives, develop procedures, and guide teams across multiple facilities and markets, ensuring inspections readiness and

Qualifications

• DVM or PhD in area of biomedical sciences or related science with at least three years' experience preferred.
• Master’s degree with three years of regulatory experience or five years of related industry experience.
• Bachelor's Degree with minimum eight years of relevant industry or regulatory experience.

Responsibilities

• Prepare, review, and oversee submissions to health authorities for new product registrations.
• Lead global project registrations and coordinate cross-functional teams.
• Define worldwide regulatory requirements and strategy for registrations and licensed facilities.
• Disseminate regulatory guidance to manufacturing, R&D, and commercial teams.
• Maintain regulatory archives and manage information systems.
• Provide coaching and development to regulatory professionals.

Skills

Leadership

Excellent communication skills

Fluent English

Problem-solving

Regulatory knowledge

Travel flexibility

Education

DVM or PhD in biomedical sciences

Master’s degree in biomedical science (preferred)

Bachelor's degree in biomedical science (required)

Tools

BIRDS

DAVID

Idea for Con

Job description

Boehringer Ingelheim USA seeks a senior regulatory affairs leader to manage submissions for new product registrations, lifecycle management, and compliance for veterinary biologics regulated by USDA. The role involves coordinating with R&D, manufacturing, and quality teams, and representing the company in health authority interactions.

The incumbent will oversee regulatory archives, develop procedures, and guide teams across multiple facilities and markets, ensuring inspections readiness and