IDEXX Laboratories

IDEXX Laboratories

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

Westbrook, ME · Senior

Sponsorship not specifiedDetected 115 days ago
Data AnalysisProject ManagementNegotiationCustomer SupportFDA RegulatoryExperimental DesignLeadershipCommunicationProblem SolvingRegulatory Affairs

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Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70

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Files H-1B transfers

1 transfer filing in the last year, covering 1 worker. Median labor-condition decision: 1072 days. An employer that already files transfers is one that can take over an existing H-1B.

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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.
  • 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.
  • Cross-functional leadership and influence, with the ability to align partners across R&D, Regulatory Affairs, Quality, and the business.
  • 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.

Requirements

  • 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.
  • Some travel is required.
  • The following experience is highly valued and would accelerate success in the role, but is not required.
  • Experience with outside-the-US (OUS) licensing in markets such as Japan, Germany, and others.
  • 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.
  • What you can expect from us:

Compensation

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

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.
  • If you're thinking about relocating for this role, here are a few things to know about living in Maine (often called "Vacationland").
  • The Westbrook, ME area provides great access to active downtown areas and the outdoors, with the coast and numerous mountains and hiking trails nearby.
  • You'll also find a number of large companies like ours in the area, creating a vibrant work culture.
  • You can learn more on the Portland tourism website:
  • https://www.visitportland.com/visit/resources/moving-to-maine/
  • 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

  • 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 p
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