Regulatory Affairs Bio Lead: USDA & Global Compliance

Boehringer Ingelheim Pharmaceuticals, Inc.; Athens (GA); On-site; USD 150,000 - 190,000; Full time

Job summary

Boehringer Ingelheim Pharmaceuticals, Inc. is seeking a regulatory professional to lead submissions and provide input for regulatory filings and product lifecycle management for veterinary biologics in the USA.

You will coordinate with manufacturing, R&D, and commercial teams to ensure compliance with USDA 9CFR guidance and related regulations. The role requires strong regulatory knowledge, experience with major agencies, and the ability to mentor colleagues while managing multiple projects.

Qualifications

• Master’s degree in biomedical science or related field with 3+ years of regulatory experience.
• Bachelor's degree in biomedical science or related field with at least 5 years of industry or regulatory experience.
• In lieu of degree, 10 years of industry experience and 5 years regulatory experience.
• Knowledge of US and international regulatory requirements.
• Experience interacting with major regulatory agencies and discussing scientific aspects with them.
• Strong business acumen and diplomacy in interactions.
• Ability to lead multidisciplinary teams and provide regulatory assessments.

Responsibilities

• Ensure timely and quality submissions to maintain compliance with 9CFR and USDA guidelines in collaboration with manufacturing, QA, QC and R&D.
• Lead projects and possibly manage 1–2 people; support global registration projects for BI manufacturing sites.
• Provide regulatory guidance and intelligence to cross-functional teams on regulations and guidance.
• Maintain regulatory archives and document management systems and ensure compliance.
• Develop, document and assess regulatory processes to comply with federal, state and local regulations.
• Develop relationships with federal and state regulatory contacts and interpret legislation and guidance.
• Maintain knowledge of relevant regulations and act as regulatory SME for USDA/state regulations.
• Provide coaching and development to regulatory professionals.
• Escalate risks related to compliance or supply continuity with mitigation strategies.

Education

Master’s degree in biomedical science or related field

Bachelor's degree in biomedical science or related field

10 years industry experience and 5 years regulatory experience in lieu of degree

Job description

Boehringer Ingelheim Pharmaceuticals, Inc. is seeking a regulatory professional to lead submissions and provide input for regulatory filings and product lifecycle management for veterinary biologics in the USA.

You will coordinate with manufacturing, R&D, and commercial teams to ensure compliance with USDA 9CFR guidance and related regulations. The role requires strong regulatory knowledge, experience with major agencies, and the ability to mentor colleagues while managing multiple projects.