Manager, 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 Manager of US Animal Health Regulatory Intelligence and External Engagement for Pharmaceuticals and Biologics plays a pivotal role in keeping Boehringer-Ingelheim (BI) agile and proactive amid evolving US regulatory requirements. This role is responsible for systematically tracking, interpreting, and communicating regulatory trends and policy changes that impact animal health pharmaceuticals and biologics. The manager delivers clear, actionable insights to internal stakeholders, supporting decision-making, risk mitigation, and strategic planning.

Key activities for this role include developing and maintaining robust regulatory intelligence databases and tools, coordinating internal regulatory information exchange sessions, drafting policy briefs, and preparing impact assessments. The manager also monitors legislative proposals, regulatory guidance documents, and relevant scientific publications. The incumbent will design internal newsletters or bulletins to keep teams informed of key global updates. The manager serves as a key contact and representative for internal Global Innovation and Global Supply project teams responsible for new registrations and life cycle management as well as external trade association working groups.

Externally, the Manager of US Animal Health Regulatory Intelligence and External Engagement for Pharmaceuticals and Biologics supports and leads the preparation of data-driven materials for meetings with regulatory agencies (FDA-CVM, USDA-CVB, EPA, and state authorities), manages regulatory intelligence tracking dashboards, and actively supports the company’s participants in industry associations, working groups, and professional forums to advocate for BI’s interests. The manager also helps organize stakeholder engagement events, liaises with external consultants and legal advisors, and coordinates BI’s contributions to regulatory consultations and comment periods.

By cultivating strong networks both inside and outside the company, the manager enhances BI’s visibility and ensures the organization is well-positioned to anticipate and respond to regulatory opportunities and challenges.

Duties & Responsibilities

Monitor and Analyze Global and US Regulatory Trends:

• Monitors global regulatory trends, policy changes, and emerging issues.
• Analyzes and provides insights and interpretation of regulatory developments for impact on business, new product registrations, life cycle management, global supply, external partners, and customers.
• Maintains a centralized repository of regulatory intelligence.
• Leads preparation of company responses to regulatory proposals and public consultations.
• Serves as a key contact for the company to leverage network of internal and external subject matter experts to ensure the company response is scientifically robust and policy development is forward looking.

Execute Regulatory Intelligence and External Engagement Strategies, and Policy Development Initiatives:

• Executes the regulatory intelligence strategy for the US Animal Health business in collaboration with US and Global stakeholders.
• Provides insights and recommendations to internal stakeholders on regulatory changes and opportunities.
• Translates regulatory intelligence into actionable recommendations for internal and external stakeholders including project teams for life cycle management and new product registrations.
• Executes the development of BI’s regulatory external engagement positions and their integration into strategic planning processes.
• Reports and communicates to internal stakeholders regulatory shifts and assess potential business impact.
• Contributes to proactive regulatory strategy development.

Team Collaboration, Professional Development & Operational Excellence:

• Collaborates with internal stakeholders to foster a high-performing culture.
• Actively contributes to the success of the US RAPV function by driving alignment and collaboration across teams.
• Drafts and ensures cross-functional review of SOPs and related documents, within an environment of continuous improvement.
• Mentors and guides junior regulatory team members, fostering a culture of collaboration, innovation, and regulatory excellence.
• Develops training materials for internal and external stakeholders.

Execution of External Engagement & Advocacy:

• Represents the company in industry associations, working groups, and interactions with regulatory bodies.
• Leads preparation of company responses to public consultations and draft regulations.
• Builds and maintains relationships with key external stakeholders (e.g., FDA-CVM, USDA-CVB, and State Health Authorities).

Process Improvement & Capability Building:

• Develops and refines tools, templates, and processes for intelligence gathering and sharing.
• Trains internal teams on regulatory trends and external engagement best practices.
• Creates work instructions and SOPs to ensure cross-functional operational efficiency and efficacy, including internal and external stakeholder mapping.

Leads Performance Monitoring & Continuous Improvement:

• Tracks project performance metrics and regulatory outcomes to identify areas for improvement.
• Implements best practices and lessons learned to enhance future regulatory project execution.

Requirements

• Bachelor’s degree in pharmacy, life sciences, or a related field is required; Advanced degree (e.g., Master’s, DVM, PhD) is preferred.
• Minimum of five (5) years of experience in the pharmaceutical or animal health industry, with a focus on regulatory affairs.
• Experience in regulatory intelligence, policy development, and advocacy.
• Experience with regulatory submissions and health authority interactions.

Leadership Experience:

• Familiarity with US regulatory requirements for pharmaceuticals and biologics.
• Demonstrated success in collaborating with cross-functional teams.
• Experience in influencing and negotiating with external stakeholders, including regulatory authorities and industry associations.

Skills and Competencies:

• 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.
• Proficiency in regulatory databases, Microsoft Office applications, and other relevant IT tools.
• Ability to manage multiple tasks, prioritize effectively, and meet deadlines.

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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