Manager, RA Pharma Safety & Efficacy

Boehringer Ingelheim; Johns Creek (GA); On-site; USD 130,000 - 170,000; Full time

Job summary

Boehringer Ingelheim is seeking a Manager, RA Pharma Safety & Efficacy in the US to lead regulatory safety and efficacy strategy for development programs. You will coordinate with global teams, prepare FDA communications, and drive timelines to approvals from a base in Johns Creek, GA.

You will oversee regulatory strategy, ensure compliance with US requirements, and facilitate governance discussions with internal teams and external stakeholders to support successful product registrations.

Qualifications

• Advanced degree (DVM or PhD) with 2+ years in Regulatory Affairs in pharma.
• Master in relevant science with 7+ years in Regulatory Affairs in pharma.
• Excellent command of English (written and spoken).
• Regulatory Affairs experience in pharma industry required.
• Intrapreneurial spirit with strong compliance and time management.
• Ability to collaborate in a global organization and manage multiple projects.
• Effective communicator with negotiation and interpersonal skills.
• Self-motivated team player who can drive change and handle high workloads.

Responsibilities

• Represent US regulatory safety/efficacy in global development projects.
• Provide regulatory strategy for assigned projects to meet timelines.
• Lead FDA meetings and submissions for assigned projects.
• Link regulatory information to internal and external stakeholders (FDA).
• Participate in governance reviews and project team meetings.
• Support infrastructural projects and maintain regulatory tools.

Skills

DVM/PhD

Regulatory Affairs

English fluency

Global collaboration

Time management

Education

DVM or PhD in relevant discipline

Master in relevant science

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.

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)
• Must be 18 years of age or older

Our Company

Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry's top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long‑term perspective, embedding sustainability along the entire value chain. Our approximately 54,300 employees serve over 130 markets to build a healthier and more sustainable tomorrow. Learn more at www.boehringer-ingelheim.com.

Why Boehringer Ingelheim?

With us, you can develop your own path in a company with a culture that knows our differences are our strengths - and break new ground in the drive to make millions of lives better.

Here, your development is our priority. Supporting you to build a career as part of a workplace that is independent, authentic and bold, while tackling challenging work in a respectful and friendly environment where everyone is valued and welcomed.

Alongside, you have access to programs and groups that ensure your health and wellbeing are looked after - as we make major investments to drive global accessibility to healthcare. By being part of a team that is constantly innovating, you'll be helping to transform lives for generations.

Want to learn more? Visit https://www.boehringer-ingelheim.com