Dist. Scientist, Regulatory Liaison

Job Description

Position Overview

The Executive Director, Regulatory Liaison, Companion Diagnostics/In Vitro Diagnostics (CDx/IVD), serves as a senior regulatory leader and subject matter expert responsible for developing and overseeing regulatory strategies for companion diagnostics and other in vitro diagnostic products supporting the company’s development portfolio.

This individual partners closely with colleagues across Research and Development, including Clinical Research, Biomarker Development, Translational Medicine, Statistics, Regulatory Affairs, and other relevant functions, to support the timely development and global registration of diagnostic products. The Executive Director also works directly with external diagnostic partners and regulatory authorities to align on regulatory requirements and development strategies.

The Executive Director provides strategic leadership and oversight for assigned programs and manages a team of regulatory professionals supporting multiple projects. The role requires strong scientific and regulatory judgment, the ability to operate independently in complex and evolving areas, and the ability to communicate effectively with senior leaders and other internal and external stakeholders.

Primary Responsibilities

• Develop and oversee global regulatory strategies for companion diagnostics and other in vitro diagnostic products supporting the company’s development portfolio.

• Provide strategic and tactical CDx/IVD regulatory guidance to product development teams, regulatory liaisons, and senior leaders to support program planning and decision-making.

• Manage regulatory activities related to the development, registration, approval, and lifecycle management of companion diagnostics and other IVD products.

• Provide regulatory leadership for complex programs or major components of high-priority programs.

• Assess the impact of diagnostic and drug regulations on diagnostic development, clinical development, and global registration strategies.

• Review regulatory strategies for assigned products and ensure that plans are scientifically sound, compliant with applicable requirements, and aligned with broader development objectives.

• Apply high-level scientific and regulatory judgment to complex, novel, or unprecedented issues.

• Identify regulatory risks and develop pragmatic, scientifically informed approaches that maintain compliance while supporting program objectives and timelines.

• Collaborate across organizational and geographic boundaries to facilitate the timely and proactive resolution of regulatory issues.

• Communicate with and manage multiple senior stakeholders across Research and Development and other relevant functions, providing awareness of program risks, regulatory issues, and potential mitigation strategies.

• Lead regulatory interactions with external diagnostic partners and support alignment on co-development requirements, responsibilities, timelines, and regulatory deliverables.

• Oversee or contribute to the preparation, review, and approval of diagnostic regulatory submissions, including pre-submission materials, Investigational Device Exemption submissions, premarket approval applications, 510(k) submissions, and other applicable regulatory filings.

• Lead or support interactions with regulatory authorities, including the preparation of briefing documents, development of meeting strategies, and participation in regulatory agency meetings.

• Review and approve regulatory communications and materials intended for submission to, or discussion with, regulatory authorities.

• Review and approve background packages and other regulatory materials to ensure clarity, accuracy, consistency, and comprehensive presentation of relevant issues.

• Review labeling and manage labeling negotiations with regulatory authorities, as appropriate, to support compliant labeling consistent with the company’s development objectives.

• Partner with international colleagues and diagnostic partners to identify appropriate regulatory pathways and support global development and registration activities.

• Participate in regulatory due diligence involving potential diagnostic partners, development agreements, licensing opportunities, and external products or technologies.

• Support external scientific and regulatory engagement, as appropriate, including interactions with industry organizations, regulators, and other stakeholders.

• Monitor relevant regulatory developments and contribute to regulatory policy and advocacy activities related to companion diagnostics and in vitro diagnostics.

• Represent the company, as appropriate, in external initiatives and interactions with regulatory authorities.

Leadership and People Management Responsibilities

• Lead and manage a team of regulatory professionals responsible for supporting diagnostic programs across the development portfolio.

• Assign regulatory liaisons to projects and manage resources and priorities across programs.

• Recruit and onboard qualified staff, as needed, to support the evolving portfolio and organizational responsibilities.

• Provide technical and professional leadership to team members and support their development through coaching, mentoring, performance management, development planning, and career guidance.

• Establish clear expectations and promote consistent, high-quality regulatory practices across the team.

• Foster an inclusive and collaborative working environment that encourages scientific rigor, constructive challenge, accountability, and effective cross-functional partnership.

Education Requirements

Required:

• Bachelor’s degree in a biological science, chemistry, engineering, regulatory science, or a related discipline, with a minimum of 12 years of relevant drug-development or regulatory experience, including substantial experience in regulatory affairs.

Acceptable advanced-degree combinations may include:

• Master’s degree in a relevant discipline with a minimum of 10 years of relevant experience; or

• Doctoral degree, such as a Ph.D., M.D., Pharm.D., or equivalent degree, with a minimum of 7 years of relevant experience.

• Relevant experience should include significant responsibility for diagnostic regulatory strategy, diagnostic product development, or the regulatory development of products involving companion diagnostics or other IVDs.

Required Experience and Skills

• Significant regulatory experience in companion diagnostics and/or in vitro diagnostics.

• Demonstrated knowledge of diagnostic product development and the regulatory requirements applicable to companion diagnostics and IVDs.

• Experience developing regulatory strategies and supporting regulatory submissions for diagnostic products.

• Demonstrated experience interacting with the U.S. Food and Drug Administration or other regulatory authorities on diagnostic development and registration matters.

• Strong scientific knowledge, professional credibility, and familiarity with regulatory requirements across relevant global markets.

• Ability to interpret evolving regulatory requirements and apply them to complex development programs.

• Demonstrated ability to develop creative and pragmatic regulatory strategies for complex or unprecedented issues.

• Experience leading high-performing teams or projects and managing multiple priorities in a matrixed environment.

• Ability to communicate complex scientific and regulatory issues clearly and effectively to senior leaders, development teams, diagnostic partners, and regulatory authorities.

• Outstanding written, verbal, interpersonal, negotiation, and presentation skills.

• Strong organizational skills, sound judgment, and the ability to work independently while maintaining effective collaboration across functions.

• Demonstrated leadership attributes, including the ability to build relationships, influence decisions, manage conflict constructively, and develop regulatory professionals.

Preferred Experience and Skills

• Advanced degree in a biological science, chemistry, engineering, regulatory science, medicine, pharmacy, or a related discipline.

• Experience supporting global development and registration of companion diagnostic or IVD products.

• Experience with diagnostic co-development partnerships and associated regulatory agreements, responsibilities, and deliverables.

• Experience with diagnostic regulatory submissions, including IDEs, PMAs, 510(k)s, or comparable submissions outside the United States.

• Experience supporting regulatory due diligence, business-development transactions, or licensing activities involving diagnostic products or technologies.

• Knowledge of evolving regulatory policies and expectations affecting companion diagnostics, in vitro diagnostics, biomarker-driven drug development, and precision medicine.

Required Skills:

Diagnostics Development, Global Regulatory, In Vitro Diagnostic Medical Devices, Leadership, Oncology Drug Development, R&D Strategy, Regulatory Compliance, Regulatory Experience, Regulatory Filings, Regulatory Strategy Development, Scientific Leadership, Stakeholder Management, Strategic Analysis, Team Management, Training and Development

Preferred Skills:

Diagnostics, In Vitro Diagnostics (IVD)

Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)

Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088\_EEOC\_KnowYourRights\_10\_20.pdf)

EEOC GINA Supplement

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)

The primary location for this posting is:

USA - Maryland - Rockville

Where required by law, the compensation range for this role is provided below.

The salary range for the primary location of this role is:

$231,900.00 - $365,000.00

This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits .

Additional location(s): Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

Additional location(s) Compensation Information:

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Remote

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

11/24/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID: R425446