IDEXX Laboratories

Senior R&D Manager — New Product Development & Regulatory Licensing

Westbrook, ME · Senior

Sponsorship not specifiedDetected 29 days ago

Data AnalysisProject ManagementNegotiationCustomer SupportFDA RegulatoryExperimental DesignLeadershipCommunicationProblem SolvingRegulatory Affairs

About the role

IDEXX defines innovation in the industries we serve with a world-class product portfolio and an impressive pipeline focused on the future.
You will assign work, establish performance metrics, monitor activities, and evaluate performance.
You will plan and organize this work, provide for adequate staffing and resources, and keep it on schedule. - You will serve as the internal subject matter expert on the regulatory strategy for each product in your portfolio.

Responsibilities

You will lead and develop a team of scientific employees, including managers and individual contributors across a multi-level organization.
You will foster a high-performing, collaborative, and accountable team environment, define best practices and standardization for technical licensing activities and documentation, and lead the development of your group's procedures while contributing to the strategy and direction of the function.
You will collaborate with Regulatory Affairs to lead the technical strategy for the registration of newly developed diagnostic products in the US and internationally.
You will own the technical direction for study design, protocol authoring, execution, data analysis, and report documentation, directing and advising R&D teams to ensure successful licensure.
You will develop and drive regulatory strategies on a multi-year horizon, take a holistic approach from concept through post-license activities, and design innovative, business-optimized approaches that balance scientific rigor with operational efficiency.
You will partner cross-functionally with Regulatory Affairs and other internal stakeholders to ensure alignment and readiness for submission and review, and you will proactively identify and mitigate risks related to study design, regulatory acceptance, and execution timelines.
You will educate internal stakeholders - including R&D partners, business leaders, and senior leadership - on regulatory requirements, project risks, timelines, and scope to enable informed decision-making and prioritization, translating complex regulatory frameworks and product attributes into clear, actionable insights for both technical and executive audiences.
In partnership with Regulatory Affairs, you will help educate regulatory agency reviewers on the technical aspects of our products, including the rationale for proposed study designs and processes, and you will influence agency acceptance of novel and non-traditional methodologies.
Demonstrated ability to lead technical strategy for product registration, including experimental design, protocol authoring, execution, data analysis, and regulatory report documentation.
Strong project management skills, including the ability to develop timelines, conduct risk assessments, define scope, and manage work streams across multi-year programs.

Requirements

PhD required in the life sciences or related areas along with at least 10 years of industrial experience working on the development of licensed diagnostic or pharmaceutical products regulated by a government agency.
depth in any one of these regulatory environments is what matters, and the ability to transfer that expertise to veterinary diagnostics.
7+ years of supervisory or managerial experience, with in-depth experience in the areas managed and proven leadership skills is required.
Experience as a manager of managers or leading a multi-level organization is highly valued.
People-leadership skills, including team development, engagement, and the ability to direct and advise scientific teams as well as define best practices and standardization.
Some travel is required.
Experience with outside-the-US (OUS) licensing in markets such as Japan, Germany, and others.
Infectious-disease subject matter expertise.

Compensation

Salary range starting at $160,000 based on experience
Opportunity for annual cash bonus and company equity

Benefits

Opportunity for annual cash bonus and company equity
Health / Dental / Vision Benefits Day-One
Additional benefits including but not limited to financial support, pet insurance, mental health resources, volunteer paid days off, employee stock program, foundation donation matching, and much more

Company info

In this role as Senior R&D Manager - New Product Development & Regulatory Licensing, you will lead a team of talented scientists through the development and regulatory licensing of newly developed diagnostic products, partnering closely with Regulatory Affairs to bring those products to market in the US and around the world.
You will be joining an innovative, fast-paced environment with a strong focus on employee culture and development, where your leadership directly shapes how our newest diagnostics reach the veterinarians and customers who rely on them.
We're proud of the work we do, because our work matters.
An innovation leader in every industry we serve since 1983, our team members help pet owners worldwide keep their companion animals healthy and happy, ensure safe drinking water for billions, and help farmers protect livestock and poultry from disease.
We have customers in over 175 countries and a collaborative global workforce.
Our culture embraces challenges and encourages learning and discovery.
At IDEXX, you'll be supported by competitive compensation, incentives, and benefits while enjoying purposeful work that drives improvement.
If meaningful work and a sense of purpose are at the top of your list, you'll find it here.
Let's pursue what matters together.
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IDEXX values a diverse workforce and workplace and strongly encourages women, people of color, LGBTQ+ individuals, people with disabilities, members of ethnic minorities, foreign-born residents, and veterans to apply.
IDEXX is an equal opportunity employer.
Applicants will not be discriminated against because of race, color, creed, sex, sexual orientation, gender identity or expression, age, religion, national origin, citizenship status, disability, ancestry, marital status, veteran status, medical condition, or any protected category prohibited by local, state, or federal laws.
While we appreciate our staffing partners, we are unable to accept unsolicited agency resumes.

Visa & Work Authorization

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