Regulatory Affairs Bio Lead – USDA Vet Biologics

Boehringer Ingelheim; Athens (GA); Híbrido; USD 120.000 - 170.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Hybrid work environment

Descripción de la vacante

Boehringer Ingelheim Animal Health USA in Athens, GA seeks a Regulatory Affairs professional to oversee regulatory filings and lifecycle management for licensed veterinary biologics. You will collaborate with Manufacturing, R&D, and Commercial Ops to ensure timely submissions and inspection readiness across US facilities.

The role requires mastery of 9CFR and CVB guidance, strong communication, and the ability to mentor teams while maintaining regulatory archives and coordinating with federal

Formación

• Master's or Bachelor's degree in biomedical science or related field with 3–5 years of regulatory experience.
• Experience with US regulatory agencies and writing technical submissions.
• Fluent in English and able to communicate complex scientific topics.

Responsabilidades

• Ensure timely and quality submissions based on scientific information for compliance with 9CFR and USDA guidance.
• May lead 1–2 people or more on global product registration projects and life cycle management.
• Provide regulatory guidance to manufacturing, R&D, and commercial teams on interpretation of regulations and guidance.
• Maintain regulatory archives and submission tracking, oversee document management systems.
• Develop and assess effectiveness of regulatory processes to comply with federal, state, and local regulations.
• Build professional relationships with federal and state regulators and negotiate on scientific topics.

Conocimientos

Regulatory affairs

USDA/CVB knowledge

Vaccine regulatory

Regulatory strategy

Cross-functional collaboration

Educación

Master's degree in biomedical science or related field

Bachelor's degree in biomedical science or related field

10 years of relevant industry experience in lieu of degree

Herramientas

BIRDS

DAVID

Descripción del empleo

Boehringer Ingelheim Animal Health USA in Athens, GA seeks a Regulatory Affairs professional to oversee regulatory filings and lifecycle management for licensed veterinary biologics. You will collaborate with Manufacturing, R&D, and Commercial Ops to ensure timely submissions and inspection readiness across US facilities.

The role requires mastery of 9CFR and CVB guidance, strong communication, and the ability to mentor teams while maintaining regulatory archives and coordinating with federal