Manager | AD, Regulatory Affairs Pharma Safety & Efficacy

About the role

The Manager, Regulatory Affairs (RA) Pharma Safety & Efficacy will represent the US regulatory safety and efficacy function in global development projects and provide regulatory strategy for assigned projects that leads to a reliable and efficient timeline for product approval.

The Associate Director will act as a core or subteam member in projects and program teams, anticipate changes in pertinent regulations, and define sound regulatory strategies for assigned products/projects within the team while ensuring regulatory compliance with safety and efficacy.

Responsibilities

• 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
• Works in project teams as an RA sub team member in accordance with the project governance model to drive Target Product Profile objectives
• Provide consistent regulatory advice to project teams regarding the pathways and approaches to regulatory approvals with details pertaining to time to market, costs, and robustness/marketability of each approval
• Represent company at external functions, such as trade association meetings, to support BI interests
• Participate in due diligence processes by providing input into the regulatory assessment. Participate in the evaluation of the product dossiers for regulatory compliance and suitability for registration
• Represent RA for infrastructural processes and projects
• Responsible for the successful update of regulatory tools as defined
• Serve as RA core team member for project teams
• Supports specific infrastructural projects as assigned
• Actively represents Boehringer Ingelheim at external functions in order to drive agenda with BI best interests in mind

Requirements

• Advanced degree (Doctor of Veterinary Medicine or PhD in relevant discipline) with minimum two (2) years related experience in Regulatory Affairs or equivalent/relevant experience in the pharmaceutical industry OR Masters in relevant scientific discipline with minimum seven (7) years related experience in Regulatory Affairs or equivalent/relevant experience in the pharmaceutical industry
• Excellent command of English language, both written and spoken
• Regulatory Affairs or equivalent pharma industry experience is required
• Intrapreneurial spirit while being rigorous and disciplined with compliance requirements
• Able to collaborate in a global organization and manage a full workload across multiple projects
• Effective communicator with good negotiation and interpersonal skills and the ability to form productive working relationships
• Able to meet stringent time and quality demands
• Strong team player who is collaborative with the mission of BI, but able to drive change
• Able to handle high workloads and understanding of cultural differences
• Well-developed organizational capabilities

Qualifications

• Advanced degree (Doctor of Veterinary Medicine or PhD in relevant discipline) from an accredited institution with a minimum of five (5) years related experience in Regulatory Affairs strategy/execution OR Masters from an accredited institution in relevant scientific discipline with minimum ten (10) years experience in Regulatory Affairs strategy/execution
• Excellent command of English language, both written and spoken
• At least five (5) years in Regulatory Affairs positions, or equivalent in the pharmaceutical industry
• Must include a minimum of two to three (2 to 3) years conveying exposure to authorities (e.g. in new product development or complex maintenance projects, leadership of RA subteams)
• Sound knowledge of the legal requirements for approval of veterinary medicinal products
• Awareness of the industry/direct competitor's activities
• Knowledge in relevant Regulatory Affairs areas
• Knowledge and established understanding of regulatory legislation and requirements for the development and maintenance of veterinary products with a focus on safety and efficacy aspects
• Regulatory Affairs or equivalent pharma experience in animal health is required including prior FDA/CVM/EPA interaction
• Intrapreneurial spirit while being rigorous and disciplined with compliance requirements
• Demonstrated ability to successfully collaborate in a global organization and manage a full workload across multiple projects
• Effective communicator with good negotiation and interpersonal skills and the ability to form productive working relationships at all levels across disciplines and nationalities
• Able to meet stringent time and quality demands and to initiate, develop and implement systems and strategies to ensure rapid and successful outcomes
• Self-motivated with a high degree of initiative, commitment and persistence
• Well developed organizational capabilities
• Strong team player who is collaborative with the mission of BI, but able to drive change
• Able to handle high workloads and understanding of cultural differences

Skills

• Knowledge in international product registration and/or product development is desired

Desired Skills, Experience And Abilities

• Knowledge in international product registration and/or product development is desired

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