Manager, RA Pharma Safety & Efficacy

Boehringer Ingelheim GmbH; Northern (KY); Hybrid; USD 120,000 - 180,000; Full time

Job summary

Boehringer Ingelheim is seeking a Manager, RA Pharma Safety & Efficacy to lead US regulatory strategy for development projects. You will coordinate FDA meetings, ensure US requirements are met, and link regulatory affairs to internal and external stakeholders.

The role emphasizes collaboration in a global organization, building robust regulatory plans, and driving timely product approvals across markets.

Qualifications

• Advanced degree with regulatory experience in pharma or veterinary products.
• Proven experience in regulatory strategy, FDA interactions, and dossier preparation.

Responsibilities

• Lead safety and efficacy regulatory activities for US projects.
• Coordinate information for FDA meetings and submissions.
• Provide regulatory strategy and governance to cross-functional teams.

Skills

Regulatory affairs

Pharma industry

English proficiency

Global collaboration

Education

Advanced degree (DVM or PhD)

Masters in science (7+ years)

Job 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, 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 expectation of the position holder will be to understand pertinent regulations and guidance and ensure the project team meets US requirements in development activities. The manager will be responsible for FDA meetings and submissions for their assigned projects. This role is responsible for linking regulatory affairs information to internal and external stakeholders (FDA) to ensure sufficient and efficient communication through activities such as governance review, project team meetings, planning activities and FDA communications.

Duties & 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.
• Responsible for coordinating 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.
• Provides 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.
• Represents company at external functions, such as trade association meetings, to support BI interests.
• Participates in due diligence processes by providing input into the regulatory assessment.
• Participates in the evaluation of the product dossiers for regulatory compliance and suitability for registration.
• Represents RA for infrastructural processes and projects.
• Responsible for the successful update of regulatory tools as defined.
• Supports specific infrastructural projects as assigned.

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.
• Ability 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.
• Ability to handle high workloads and understanding of cultural differences.
• Well-developed organizational capabilities.
• Self-motivated.

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).