AD, Reg Affairs Service Center

Associate Director, Ra Service Center

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 company's 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 :

Eligibility Requirements :

Desired Skills, Experience and Abilities :

All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.