AD, Reg Affairs Service Center

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 Associate Director, RA Service Center will hold full accountability for the Regulatory Affairs (RA) US outsourcing program, ensuring its successful execution and further development in alignment with the company’s strategic plan. The program focuses on globally established veterinary medicinal products and product families.

Duties & Responsibilities

• Accountable for conducting successful Requests for Information/Requests for Proposal/Pitches for RA US outsourcing.
• Strategic and technical regulatory advice to RFI/RFP/Pitch Processes – Provides expert input — both technical and strategic — to RFI/RFP/Pitch documents, ensuring alignment with business objectives and regulatory standards.
• Vendor Evaluation and Selection – Analyzes and assesses vendor responses and documentation, including feedback and impressions from vendor presentations and pitches, to support informed decision-making.
• Initiation and Support of Infrastructure Projects – Proactively initiates and/or contributes to the planning, development, and implementation of infrastructure-related projects, supporting operational efficiency and strategic objectives.
• Negotiation Excellence – Collaborates closely with Boehringer Ingelheim’s Sourcing department during vendor negotiations, contributing subject matter expertise and ensuring alignment with internal requirements and expectations while striving for competitive rates.
• Program Ownership and Strategic Oversight – Accountable for the success of the RA US outsourcing program, executed in collaboration with External Regulatory Affairs Services (ERAS). The program supports international Boehringer Ingelheim products within the existing portfolio, specifically those with multiple marketing authorizations and without regulatory data protection.
• Portfolio Management – Oversees a diverse outsourcing portfolio comprising more than 70 products (different modalities) from various heritage lines, ensuring consistent regulatory support and operational excellence across all engagements.
• Outsourcing Program Implementation – Leads the setup and operationalization of the outsourcing program, ensuring alignment with strategic and regulatory requirements.
• Governance of Maintenance and Expansion Activities – Oversees governance of ongoing maintenance activities and regulatory dossiers, particularly in the context of geographical expansion.
• Monitoring and Action Based on ERAS Reporting – Receives, reviews, and evaluates reports from ERAS, taking ownership of translating insights into actionable steps to ensure continuous improvement and compliance.
• Escalation Management – Acts as the primary point of contact for internal escalation issues within Boehringer Ingelheim, with responsibility for resolving first-level escalations related to ERAS.
• Effective management of allocated budget – Responsible for the efficient use of the allocated budget for Regulatory Affairs (RA) US outsourcing services, ensuring optimal value delivery.
• Invoice Verification – Reviews and validates incoming invoices for accuracy and compliance with contractual arrangements.
• Budget Monitoring and Planning – Continuously monitors and plans budget utilization, including the development and enhancement of tools to support financial tracking and forecasting.
• Financial Reporting – Provides regular budget reports to relevant stakeholders, including Finance and Controlling, ensuring transparency and alignment with organizational financial objectives.
• Accountability for Managing external partners within outsourcing program.

Requirements

• Advanced degree (PharmD, DVM, PhD, or MSc) in Life Sciences, Pharmacy, Veterinary Medicine, or a related field required.
• Additional qualifications in Regulatory Affairs (e.g., RAC certification) are considered an asset.
• Capabilities & Professional Expertise.
• Demonstrates a high level of professional capability and strategic influence in international regulatory affairs, with a minimum of five years’ experience managing regulatory procedures across the United States, European markets (CP, DCP, MRP), and non-EU regions.
• Proven expertise in dossier compilation and the use of regulatory databases is essential to ensure compliance, efficiency, and data integrity across global submissions.

Project Leadership & Strategic Delivery

• Fluency in English and the ability to lead complex, cross-functional regulatory projects are critical.
• Strong leadership in managing change, delegating effectively, and driving results across diverse regulatory landscapes and organizational boundaries.

Core Competencies – The incumbent must bring advanced capabilities in:

• Strategic Thinking: Translating regulatory complexity into actionable strategies that support global product maintenance and expansion.
• Decision-Making & Persistence: Navigating ambiguity and regulatory challenges with resilience and sound judgment.
• Communication & Negotiation: Influencing internal and external stakeholders across disciplines and cultures.
• Organizational & Analytical Skills: Managing multiple priorities with precision and clarity.
• Cross-Disciplinary & Cross-Cultural Collaboration: Building trust and alignment across global teams and vendor networks.

Impact & Influence

• Significantly contributes to Boehringer Ingelheim’s regulatory success, operational excellence, and long-term innovation strategy.
• Through expert leadership and strategic execution, ensures that regulatory outsourcing delivers measurable value, compliance, and stakeholder satisfaction.

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:

• External Partner Management – Oversees and manages relationships with external service providers within the outsourcing program, ensuring alignment with strategic objectives and operational standards.
• Primary Contact for Strategic and Escalation Matters – Serves as the first point of contact for external partners regarding strategic guidance and the resolution of escalation issues.
• Contractual Compliance and Advice – Acts as the RA liaison for all matters related to the Frame Service Agreement, work orders, and purchase orders issued by contractors to Boehringer Ingelheim, ensuring compliance and smooth execution of contractual obligations.

Steering Committee Meetings with Senior Management:

• Organizes, leads, and moderates Steering Committee Meetings involving Senior Management from Boehringer Ingelheim and the external partner.
• Ensures structured dialogue, strategic alignment, anticipation of future outsourcing needs and effective decision-making across both organizations.

Accountability for Management of internal Boehringer Ingelheim stakeholders:

• Actively engages with internal stakeholders by facilitating structured feedback exchange regarding the outsourcing program.
• Ensures that external vendors operate in alignment with Boehringer Ingelheim’s current processes and receive all required training.
• Stakeholder satisfaction is monitored through periodic surveys, with actionable insights derived from the feedback to drive continuous improvement.

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