Manager | Associate Director, Regulatory Affairs Pharma Safety & Efficacy

Overview

Manager | Associate Director, Regulatory Affairs Pharma Safety & Efficacy — Boehringer Ingelheim

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Describe the regulatory safety & efficacy function in global development projects, provide regulatory strategy, and ensure US requirements are met in development activities. The role involves FDA meetings and submissions, and linking regulatory information to internal and external stakeholders to ensure effective communication through governance reviews, project team meetings, planning activities, and FDA communications.

• Responsible for the safety and efficacy part of the dossier for new veterinary products as well as life-cycle management of existing products for assigned projects/products in US and other markets, when applicable
• Coordinate technical input for Freedom of Information Summary and product labeling for assigned projects
• Collaborate in project teams as an RA sub team member to drive Target Product Profile objectives
• Provide regulatory advice to project teams regarding pathways and approaches to regulatory approvals with details on time to market, costs, and robustness/marketability
• Represent the company at external functions (e.g., trade association meetings) to support BI interests
• Participate in due diligence processes by providing regulatory input
• Evaluate product dossiers for regulatory compliance and suitability for registration
• Represent RA for infrastructural processes and projects
• Coordinate successful updates of regulatory tools as defined
• Support specific infrastructural projects as assigned

• Responsible for the safety and efficacy part of the dossier for new veterinary products as well as life-cycle management of existing products for assigned projects/products in US and other markets, when applicable
• Coordinate technical input for Freedom of Information Summary and product labeling for assigned projects
• Work in project teams to drive Research Profile/Target Product Profile and Quality Target Profile
• Provide regulatory advice to project teams regarding pathways to regulatory approvals with details on time to market, costs, and robustness/marketability
• Serve as RA core team member for project teams
• The RA core team role includes steering all regulatory aspects of development and leading subteams
• Serve as Subject Matter Expert on the current US regulatory environment and potential trends; recommend proactive approaches to regulatory issues
• Facilitate partnerships with key regulatory agency review staff
• Participate in due diligence with regulatory assessment and expertise
• Evaluate product dossiers for regulatory compliance and suitability for registration
• Proactive representation of RA for infrastructural processes and projects
• Lead or support infrastructural projects as assigned
• Represent the company at external functions to drive BI interests
• Communicate with regulatory authorities and industry associations
• Proactively seek contact with regulatory authorities and position BI as a trusted partner
• Maintain a balanced relationship with authorities

Requirements

• Advanced degree (Doctor of Veterinary Medicine or PhD in relevant discipline) with minimum two (2) years related Regulatory Affairs or equivalent/pharmaceutical industry experience OR Master’s in relevant scientific discipline with minimum seven (7) years related experience
• Excellent command of English, written and spoken
• Regulatory Affairs or equivalent pharma industry experience required
• Intrapreneurial spirit with rigorous compliance
• Ability to collaborate in a global organization and manage multiple projects
• Effective communication, negotiation, and interpersonal skills
• Ability to meet stringent time and quality demands
• Strong teamwork and change-driving ability
• Ability to handle high workloads and understand cultural differences
• Well-developed organizational capabilities
• Self-motivated

• Advanced degree (Doctor of Veterinary Medicine or PhD in relevant discipline) with minimum five (5) years Regulatory…