Boehringer Ingelheim GmbH
Director, US RA Intelligence and External Engagement
Boehringer Ingelheim GmbH, Duluth, Georgia, United States, 30155
Overview
Director, US RA Intelligence and External Engagement. The Director will lead and shape Boehringer Ingelheim’s regulatory intelligence and external engagement strategy for the US Animal Health business. This role ensures proactive engagement with health authorities, industry associations, and other external stakeholders to shape the regulatory environment, advocate BI’s interests, and drive strategic initiatives. As a senior leader and deputy to the Vice President, US Regulatory Affairs and Pharmacovigilance (US RAPV), this role provides organizational leadership and guidance to support BI’s US Animal Health business. Duties & Responsibilities
Strategic Leadership in Regulatory Affairs and Deputized for the Vice President, US RAPV: act as primary delegate in the VP's absence, provide leadership and decision-making authority across all aspects of US Regulatory Affairs and Pharmacovigilance; represent the VP in high-level internal and external meetings; lead US Animal Health regulatory strategy with health authorities, industry associations, and key stakeholders; develop and implement engagement plans to advance BI’s interests and influence regulatory policies; provide continuity and senior guidance in the VP’s absence. Leadership in External Communication and Engagement: serve as BI’s senior representative in external communications with US health authorities (FDA-CVM, USDA, State Authorities), industry associations, and other stakeholders; lead BI’s external engagement strategy and communicate BI’s regulatory positions and advocacy efforts; build and maintain strong relationships with external stakeholders; represent BI in industry forums and regulatory working groups to advocate policies aligned with BI’s objectives. Strategic Regulatory Intelligence, Policy Development, and Risk Management: lead development and execution of a comprehensive regulatory intelligence strategy for US Animal Health; provide strategic insights on regulatory changes and opportunities; drive BI’s regulatory policy positions and ensure dissemination of regulatory intelligence across the organization; oversee cross-functional strategic initiatives addressing regulatory challenges and lifecycle management; proactively assess and mitigate regulatory risks. Driving Strategic Initiatives: lead initiatives to accelerate regulatory pathways, including conditional license registrations and innovative approval approaches; collaborate with cross-functional teams to identify opportunities; provide senior-level oversight on regulatory strategies for new product approvals, lifecycle management, and compliance with evolving requirements. Requirements
Doctoral Degree (e.g., PhD, DVM) or Master’s Degree in pharmacy, life sciences, or a related field required. Minimum of ten (10) years of experience in the pharmaceutical or animal health industry, with a focus on regulatory affairs. Proven expertise in regulatory intelligence, policy development, and advocacy. Hands-on experience with regulatory submissions, health authority interactions, and lifecycle management. Strong understanding of US and international regulatory requirements for pharmaceuticals and biologics. Integrative personality with good interpersonal skills; willingness and ability to create and share knowledge. Critical thinker with ability to organize workload, work under pressure, define priorities, and deliver under tight timelines. Strategic and visionary, able to navigate ambiguity and balance short-term priorities with long-term goals. Excellent oral and written communication skills; ability to apply scientific knowledge in discussions. Willingness to learn continuously, adapt to change, and improve efficiency. Skilled in IT applications (Microsoft Office, regulatory databases) and willingness to learn related tools. Excellent project management and organizational skills; ability to manage multiple priorities in a dynamic environment. Demonstrated success in leading cross-functional teams and managing direct reports; experience influencing external stakeholders. Proficiency in regulatory databases and related IT tools. Eligibility Requirements
Must be legally authorized to work in the United States without restriction. Must be willing to take a drug test and post-offer physical (if required). Must be 18 years of age or older. Desired Skills, Experience and Abilities
Additional Duties & Responsibilities : Leadership, Team Development, and Organizational Excellence
Provides senior leadership to the US Regulatory Intelligence and External Engagement team, fostering collaboration, innovation, and excellence. Mentors and develops team members, ensuring skills align with BI’s regulatory and business objectives. Acts as a role model for leadership, upholding BI’s values and commitment to regulatory excellence. Contributes to the overall success of the US RAPV function by driving cross-team alignment. Direct Cross-Functional Collaboration and Influence
Drives alignment across US and global functions (Legal, Corporate Affairs, Commercial, Pharmacovigilance, Global Innovation). Serves as a senior advisor and influencer, embedding regulatory perspectives in business decisions. Leads cross-functional coordination on regulatory intelligence, policy development, and external engagement strategies. Guides cross-functional teams on regulatory matters in line with BI’s priorities. Organizational Leadership and Strategic Contribution
Member of the US Animal Health Regulatory Affairs leadership team; aligns with BI’s global regulatory strategy. Provides senior input on BI’s regulatory and business strategies; advises senior leadership on opportunities and challenges. Crisis Management and Issue Resolution
Leads regulatory crisis management and issue resolution to minimize business impact; supports stakeholders during crises; conducts post-crisis reviews for improvements.
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Director, US RA Intelligence and External Engagement. The Director will lead and shape Boehringer Ingelheim’s regulatory intelligence and external engagement strategy for the US Animal Health business. This role ensures proactive engagement with health authorities, industry associations, and other external stakeholders to shape the regulatory environment, advocate BI’s interests, and drive strategic initiatives. As a senior leader and deputy to the Vice President, US Regulatory Affairs and Pharmacovigilance (US RAPV), this role provides organizational leadership and guidance to support BI’s US Animal Health business. Duties & Responsibilities
Strategic Leadership in Regulatory Affairs and Deputized for the Vice President, US RAPV: act as primary delegate in the VP's absence, provide leadership and decision-making authority across all aspects of US Regulatory Affairs and Pharmacovigilance; represent the VP in high-level internal and external meetings; lead US Animal Health regulatory strategy with health authorities, industry associations, and key stakeholders; develop and implement engagement plans to advance BI’s interests and influence regulatory policies; provide continuity and senior guidance in the VP’s absence. Leadership in External Communication and Engagement: serve as BI’s senior representative in external communications with US health authorities (FDA-CVM, USDA, State Authorities), industry associations, and other stakeholders; lead BI’s external engagement strategy and communicate BI’s regulatory positions and advocacy efforts; build and maintain strong relationships with external stakeholders; represent BI in industry forums and regulatory working groups to advocate policies aligned with BI’s objectives. Strategic Regulatory Intelligence, Policy Development, and Risk Management: lead development and execution of a comprehensive regulatory intelligence strategy for US Animal Health; provide strategic insights on regulatory changes and opportunities; drive BI’s regulatory policy positions and ensure dissemination of regulatory intelligence across the organization; oversee cross-functional strategic initiatives addressing regulatory challenges and lifecycle management; proactively assess and mitigate regulatory risks. Driving Strategic Initiatives: lead initiatives to accelerate regulatory pathways, including conditional license registrations and innovative approval approaches; collaborate with cross-functional teams to identify opportunities; provide senior-level oversight on regulatory strategies for new product approvals, lifecycle management, and compliance with evolving requirements. Requirements
Doctoral Degree (e.g., PhD, DVM) or Master’s Degree in pharmacy, life sciences, or a related field required. Minimum of ten (10) years of experience in the pharmaceutical or animal health industry, with a focus on regulatory affairs. Proven expertise in regulatory intelligence, policy development, and advocacy. Hands-on experience with regulatory submissions, health authority interactions, and lifecycle management. Strong understanding of US and international regulatory requirements for pharmaceuticals and biologics. Integrative personality with good interpersonal skills; willingness and ability to create and share knowledge. Critical thinker with ability to organize workload, work under pressure, define priorities, and deliver under tight timelines. Strategic and visionary, able to navigate ambiguity and balance short-term priorities with long-term goals. Excellent oral and written communication skills; ability to apply scientific knowledge in discussions. Willingness to learn continuously, adapt to change, and improve efficiency. Skilled in IT applications (Microsoft Office, regulatory databases) and willingness to learn related tools. Excellent project management and organizational skills; ability to manage multiple priorities in a dynamic environment. Demonstrated success in leading cross-functional teams and managing direct reports; experience influencing external stakeholders. Proficiency in regulatory databases and related IT tools. Eligibility Requirements
Must be legally authorized to work in the United States without restriction. Must be willing to take a drug test and post-offer physical (if required). Must be 18 years of age or older. Desired Skills, Experience and Abilities
Additional Duties & Responsibilities : Leadership, Team Development, and Organizational Excellence
Provides senior leadership to the US Regulatory Intelligence and External Engagement team, fostering collaboration, innovation, and excellence. Mentors and develops team members, ensuring skills align with BI’s regulatory and business objectives. Acts as a role model for leadership, upholding BI’s values and commitment to regulatory excellence. Contributes to the overall success of the US RAPV function by driving cross-team alignment. Direct Cross-Functional Collaboration and Influence
Drives alignment across US and global functions (Legal, Corporate Affairs, Commercial, Pharmacovigilance, Global Innovation). Serves as a senior advisor and influencer, embedding regulatory perspectives in business decisions. Leads cross-functional coordination on regulatory intelligence, policy development, and external engagement strategies. Guides cross-functional teams on regulatory matters in line with BI’s priorities. Organizational Leadership and Strategic Contribution
Member of the US Animal Health Regulatory Affairs leadership team; aligns with BI’s global regulatory strategy. Provides senior input on BI’s regulatory and business strategies; advises senior leadership on opportunities and challenges. Crisis Management and Issue Resolution
Leads regulatory crisis management and issue resolution to minimize business impact; supports stakeholders during crises; conducts post-crisis reviews for improvements.
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