Senior Regulatory Affairs Manager, Veterinary Biologics

Boehringer Ingelheim GmbH; United States; On-site; USD 120,000 - 170,000; Full time

Job summary

Boehringer Ingelheim seeks a Regulatory Affairs professional to oversee submissions for veterinary biologics, guide interdisciplinary teams, and ensure compliance with USDA 9CFR and related regulations in the USA.

The role requires strong scientific communication, ability to engage with federal and state authorities, and leadership across manufacturing, R&D, and commercial operations. BI offers competitive compensation and benefits.

Qualifications

• Master’s degree with 3 years of related industry or regulatory experience OR Bachelor's degree with 5 years relevant regulatory experience OR 10 years of experience in lieu of degree.
• Knowledge of US and international regulatory requirements for veterinary biologics and licensed facilities.
• Experience interacting with major regulatory agencies and discussing scientific aspects of programs.
• Experienced in developing and executing regulatory strategies in a regulated environment.

Responsibilities

• Ensure timely and quality submissions based on scientific information to maintain compliance with 9CFR and USDA guidance.
• Lead 1-2 people or manage global projects requiring advanced regulatory knowledge.
• Provide regulatory guidance to manufacturing, R&D, and commercial teams.
• Maintain regulatory archives and submission tracking; oversee document management systems (BIRDS, DAVID, Idea for Con).
• Develop and assess effectiveness of regulatory processes to comply with laws and BI policies.
• Engage with federal/state regulators and interpret legislation and guidance for BI needs.
• Maintain advanced knowledge of regulations and serve as regulatory SME for USDA and state rules.
• Provide coaching and succession planning for regulatory team members.
• Escalate compliance and supply continuity risks with mitigation plans.

Skills

regulatory strategy

cross-functional collaboration

scientific communication

multidisciplinary teamwork

Education

Master’s degree

Bachelor’s degree

Tools

BIRDS

DAVID

Idea for Con

Job description

Boehringer Ingelheim seeks a Regulatory Affairs professional to oversee submissions for veterinary biologics, guide interdisciplinary teams, and ensure compliance with USDA 9CFR and related regulations in the USA.

The role requires strong scientific communication, ability to engage with federal and state authorities, and leadership across manufacturing, R&D, and commercial operations. BI offers competitive compensation and benefits.