SR AD, US RA Intelligence and External Engagement

Description

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

The Senior Associate Director of US Regulatory Affairs Animal Health Intelligence and External Engagement is responsible for advancing Boehringer Ingelheim’s (BI) regulatory intelligence and engagement strategies for US Animal Health. This role leads key initiatives, builds relationships with federal and state health authorities (e.g., FDA-CVM, USDA-CVB), industry groups, and ensures BI’s proactive involvement in shaping the regulatory landscape. Working closely with the Director and senior leaders, the position translates regulatory trends across healthy authorities, scientific disciplines, and geographies, into actionable strategies and aligns efforts with BI’s business objectives. This position is a key interface with US and key market Regulatory Authorities and represents the company externally on a multinational basis with domestic and global trade associations.

The Senior Associate Director of US Regulatory Affairs Animal Health Intelligence and External Engagement provides technical regulatory expertise to our operations in the respective scope of their responsibilities: Global Innovation, Global Supply, Global Strategic Marketing, US Commercial Operations, Global and US Regulatory teams. The incumbent serves as RA Project Leader for Global and US cross-functional teams responsible for new product registrations and life cycle management.  

Duties & Responsibilities

Strategic Key Interface with Health Authorities, Trade Associations, and Stakeholders:

• Acts as subject matter expert and key representative for BI in external communications with US health authorities, industry associations, and other stakeholders.
• Develops and oversees execution of BI’s external engagement strategy, ensuring effective communication of BI’s regulatory positions and priorities.
• Builds and maintains strong relationships with external stakeholders, positioning BI as a trusted partner in the animal health regulatory space.
• Key communication interface and influencer with the animal health regulatory authorities, responsible for proactively seeking contact with regulatory authorities directly in the USA or through local and global RA as appropriate and positioning BI as a trusted and innovative partner (key account management).
• Develops and provides strategic technical regulatory insights to cross-functional teams to inform product development and lifecycle management.

Driving External Regulatory Engagement, Intelligence, and Policy Development:

• Leads the development and execution of a regulatory intelligence strategy for the US Animal Health business by serving as technical expert that can bridge the scientific considerations with the regulatory landscape in alignment with business priorities.
• Provides insights and recommendations to internal stakeholders on regulatory changes and opportunities that impact new product registrations and licensed products.
• Leads the development of BI’s technical regulatory policy positions and their integration into strategic planning processes by collaborating with internal and external subject matter experts and synthesizing a scientifically sound regulatory strategy for external engagement with federal and state health authorities.

Support Leadership with Team Development, and RA Organizational Excellence:

• Actively Leads the drafting and ensures review of SOPs and related documents, within an environment of continuous improvement.
• Leads across BI by coaching, training and advising teams and upcoming experts to advance science, technology and regulatory strategy.
• Identifies and attracts talent within and to the organization.
• Proactively shares trends with others to foster collective success within the US Regulatory Intelligence and External Engagement team, and Global Innovation, Global Supply, and Commercial, fostering a culture of collaboration, innovation, and excellence. 
• Oversees and ensures development training materials for internal and external stakeholders.
• Leads and/or participates in training initiatives related to technical or regulatory aspects of our products.
• May be responsible for writing of technical pieces for use by other departments within Global Innovation, Global Supply, or Commercial Operations.
• Mentors and develops team members, ensuring they have the skills and expertise needed to support BI’s regulatory and business objectives.
• Acts as a role model for support and collaboration within the organization, demonstrating BI’s core values and commitment to regulatory excellence.
• Drives alignment across functions and disciplines, locally and globally, to ensure the overall success of the company and US RAPV function.

Requirements

• Advanced degree in pharmacy, life sciences, or a closely related discipline is required (e.g., Master’s, DVM, PhD).
• Minimum of seven (7) years of experience in the pharmaceutical or animal health industry, with a focus on regulatory affairs.
• Demonstrated experience in regulatory intelligence, policy analysis, and supporting advocacy efforts.
• Practical experience with regulatory submissions, health authority communications, and lifecycle management activities.
• Solid understanding of US regulatory requirements for pharmaceuticals and biologics.
• Strong interpersonal and communication skills, with the ability to collaborate across internal teams and external stakeholders.
• Ability to organize and prioritize workload, manage multiple tasks under pressure, and deliver within tight timelines.
• Analytical thinker with a proactive mindset and the ability to adapt to evolving regulatory and business environments.
• Willingness to share knowledge, contribute to team learning, and engage in scientific and regulatory discussions.
• Proficiency in Microsoft Office applications and familiarity with regulatory databases and tools.
• Effective project management and organizational skills.

Leadership Experience:

• Experience leading or mentoring team members and contributing to cross-functional initiatives.
• Ability to influence internal stakeholders and support engagement with regulatory authorities and industry groups.

Skills and Competencies:

• Strategic mindset with the ability to align regulatory insights with business objectives.
• Strong written and verbal communication skills, with the ability to convey complex information clearly.
• Collaborative and adaptable, with a commitment to continuous learning and process improvement.
• Skilled in managing competing priorities in a dynamic, cross-functional environment.

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.

GI_US925

Desired Skills, Experience and Abilities

Additional Duties & Responsibilities:

Strategic Regulatory Intelligence, Policy Development, and Risk Management:

• Provides the technical regulatory expertise for development and execution of a comprehensive regulatory intelligence strategy for the US Animal Health business, ensuring timely identification and analysis of regulatory and scientific trends and emerging policies.
• Provides strategic insights and recommendations to internal stakeholders on the impact of regulatory changes and opportunities for BI.
• Develops BI’s technical and operational regulatory policy positions, ensuring alignment with BI’s business priorities and advocacy efforts.
• Oversees the appropriate mapping of internal and external stakeholders, dissemination of regulatory intelligence across the organization, ensuring all stakeholders are informed and prepared to respond to regulatory changes.
• Directs cross-functional strategic initiatives addressing emerging regulatory challenges, accelerating product approvals, and supporting life cycle management of products.
• Proactively assesses and mitigates regulatory risks to safeguard BI’s interests.
• Leads development, maintenance, and expansion of a diverse, international network of internal and external experts (including key opinion leaders, academics, consultants, industry association leaders and regulatory authorities).
• Leads negotiations with authorities and lead trade association working groups to develop policy, regulations and guidelines for the benefit of the industry.
• Creates precedents with health authorities using sound scientific data, knowledge of industry, and understanding of regulatory landscape.
• Positions BI as a trusted and innovative partner (key account management).

Contribute to Cross-Functional Collaboration and Influence:

• Provides expert consultation and advice across Boehringer-Ingelheim Animal Health to influence GI portfolio strategy, successfully advance novel modalities, complex projects and resolution of significant issues (such as, new technologies, new modalities, new product research and development, new external partnerships, global systems, policy and/or external influencing).
• Remains at the cutting edge of scientific and regulatory knowledge in the assigned field of expertise and related fields (e.g. new technologies, new modalities, new product research and development, external partnerships, global systems, policy and/or external influencing) by creating and leveraging an extensive network of external (including authorities, trade associations and competitors) and internal subject matter experts and information sources.
• Proactively communicates knowledge with relevant governance committees, leadership teams and other influential stakeholders within the organization.
• Drives alignment and strategic collaboration across US and global functions including Legal, Corporate Affairs, Commercial, Pharmacovigilance, and Global Innovation.
• Serves as a senior advisor and influencer, ensuring regulatory perspectives are embedded in business decisions and new product registration plans.
• Acts as a senior influencer within BI, driving cross-functional alignment on regulatory intelligence, policy development, and external engagement strategies.
• Develops strategic guidance to cross-functional teams on regulatory matters, ensuring alignment with BI’s business priorities anticipating regulatory trends and collaborating with global and local teams to influence new regulations and guidelines with health authorities to create regulatory predictability.