Director, 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 Director, US RA Intell. And Ext. Eng. will lead and shape Boehringer Ingelheim’s (BI) regulatory intelligence and external engagement strategy for the US Animal Health business. This role is pivotal in ensuring BI’s proactive engagement with health authorities, industry associations, and other external stakeholders to shape the regulatory environment, advocate for BI’s interests, and drive strategic initiatives. This role requires a strong understanding of US regulatory trends, emerging regulations, and their impact on BI’s Animal Health business, as well as the ability to translate these insights into actionable strategies. This position will hold significant accountability for driving regulatory strategy, external engagement, and organizational leadership. As a senior leader and deputy to the Vice President, US Regulatory Affairs and Pharmacovigilance (US RAPV), this role will play a pivotal part in ensuring the success of BI’s US Animal Health business.

Duties & Responsibilities

Strategic Leadership in Regulatory Affairs and Deputized for the Vice President, US RAPV

• Acts as the primary delegate for the Vice President, US RAPV, in their absence, providing leadership and decision-making authority across all aspects of US Regulatory Affairs and Pharmacovigilance.
• Represents the Vice President in high-level internal and external meetings, ensuring continuity in leadership, decision-making, and strategic direction.
• Leads US Animal Health regulatory strategy by representing BI in all major interactions with health authorities (FDA-CVM, EPA, USDA), industry associations, and key stakeholders.
• Develops and implements engagement plans to advance BI’s interests and influence regulatory policies.
• Serves as deputy to the Vice President, US RAPV, and provide continuity and senior guidance in their absence.

Leadership in External Communication and Engagement Shaping the External Regulatory Environment

• Serves as BI’s senior representative in external communications with US health authorities (e.g., FDA-CVM, USDA, and State Authorities), industry associations, and other key stakeholders.
• Leads BI’s external engagement strategy, ensuring proactive and effective communication of BI’s regulatory positions, priorities, and advocacy efforts.
• Builds and maintains strong, trusted relationships with external stakeholders, positioning BI as a thought leader and trusted partner in the animal health regulatory space.
• Represents BI in high-profile industry forums, trade associations, and regulatory working groups, advocating for policies and initiatives that align with BI’s business objectives.

Strategic Regulatory Intelligence, Policy Development, and Risk Management

• Leads the development and execution of a comprehensive regulatory intelligence strategy for the US Animal Health business, ensuring timely identification and analysis of regulatory trends and emerging policies.
• Provides strategic insights and recommendations to internal stakeholders on the impact of regulatory changes and opportunities for BI.
• Drives the development of BI’s regulatory policy positions, ensuring alignment with BI’s business priorities and advocacy efforts.
• Oversees the 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 lifecycle management.
• Proactively assesses and mitigates regulatory risks to safeguard BI’s interests.

Driving Strategic Initiatives

• Leads strategic initiatives focused on accelerating regulatory pathways, including opportunities for conditional license registrations and other innovative approaches to product approval.
• Collaborates with cross-functional teams to identify and capitalize on regulatory opportunities that align with BI’s business objectives.
• Provides senior-level oversight and guidance on the development and execution of regulatory strategies for new product approvals, lifecycle management, and compliance with evolving regulatory 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, to work well under pressure, define priorities and delivery under tight timelines.
• Conflict management skills.
• Strategic and visionary personality who is focused, creative, courageous and able to navigate ambiguity and can balance between short-term priorities and long-term vision.
• Excellent oral and written communications skills.
• Excellent negotiation skills.
• Willingness and ability to apply scientific knowledge and have sound scientific discussions.
• Ability and willingness to learn continuously, adapt to a changing environment and improve efficiency.
• Skilled in relevant IT applications (Microsoft Office applications as well as regulatory databases and other relevant IT applications) and willingness to learn relevant IT applications and to make use of the benefits of relevant IT applications.
• Excellent project management skills.
• Demonstrated success in leading cross-functional teams and managing direct reports.
• Experience in influencing and negotiating with external stakeholders, including regulatory authorities and industry associations.
• Strategic thinker with the ability to balance short-term priorities and long-term vision.
• Strong interpersonal and communication skills, with the ability to influence and collaborate across diverse teams.
• Excellent project management and organizational skills, with the ability to manage multiple priorities in a dynamic environment.
• Proficiency in regulatory databases, Microsoft Office applications, and other relevant 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.

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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 a culture of collaboration, innovation, and excellence.
• Mentors and develops team members, ensuring they have the skills and expertise needed to drive BI’s regulatory and business objectives.
• Acts as a role model for leadership within the organization, demonstrating BI’s core values and commitment to regulatory excellence.
• Contributes to the overall success of the US RAPV function by driving alignment and collaboration across teams and functions.

Direct Cross-Functional Collaboration and Influence

• 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 plans.
• Acts as a senior influencer within BI, driving cross-functional alignment on regulatory intelligence, policy development, and external engagement strategies.
• Provides strategic guidance to cross-functional teams on regulatory matters, ensuring alignment with BI’s business priorities.

Organizational Leadership and Strategic Contribution

• Serves as a key member of the US Animal Health Regulatory Affairs leadership team, contributing to the overall success of the function and ensuring alignment with BI’s global regulatory strategy.
• Provides senior-level input and guidance on the development and execution of BI’s regulatory and business strategies.
• Acts as a trusted advisor to senior leadership, providing insights and recommendations on regulatory opportunities and challenges.

Crisis Management and Issue Resolution

• Takes a leadership role in managing regulatory crises and resolving complex regulatory issues, ensuring minimal impact on BI’s business operations.
• Serves as a senior advisor to internal stakeholders during regulatory crises, providing guidance and support to ensure effective resolution.
• Leads post-crisis reviews to identify lessons learned and implement improvements to BI’s regulatory processes and strategies.