Principal Scientist, (Director) - Regulatory Liaison

The Director/Principal Scientist, Regulatory Affairs Liaison, is responsible for the development and implementation of worldwide regulatory strategy for their assigned projects in the General Medicine therapeutic area with a specific focus on development programs in Ophthalmology. The individual functions with a degree of independence and provide regulatory oversight for assigned products in order to optimize product labeling and obtain shortest time to approval by regulatory agencies.

You will independently manage projects, functioning as the single, accountable, global point of contact on those projects and interact independently with the Worldwide Regulatory Agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or more of our company investigational and marketed drugs/biologics. Programs may be complex with more than one indication, formulation or have an external business partner.

Coordinate the preparation, submission, and any follow-up contact with regulatory agencies and/or subsidiaries for all applications and submissions and be responsible for regulatory review and final approval for all submissions and associated documentation. Provide expertise as the Global Regulatory Lead to Product Development Teams and the regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.

**Key functions:**

+ Reports to Senior Principal Scientist (Senior Director) and/or Distinguished Scientist (Executive Director)

+ Works Independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion

+ Develops worldwide product regulatory strategy to optimize product labeling and obtain shortest time to approval by regulatory agencies for multiple indications simultaneously

+ Provide expert advice as the Global Regulatory Lead to Product Development Teams and regulatory single point-of-contact for products within and external to GRACS on regulatory issues as they arise with the developmental compounds or marketed products throughout the entire life cycle of the drug

+ Provide leadership to the staff by leading the Global Regulatory Team which coordinates cross-functional regulatory support for development programs and marketed products

+ Review and provide final approval of local registration study protocols when needed to obtain marketing authorization in secondary markets

+ Represents our Company with external organizations through direct communication with the FDA, including telephone calls and e-mail; chair meetings between company and FDA; prepare our Company's teams for meetings with FDA at any phase of drug development

+ Lead cross-functional efforts to prepare for advisory committees and may speak at the advisory committee

+ Coordinate interactions with foreign agencies through Regulatory Affairs Europe and the subsidiary registration departments to support their interactions and provide strategic direction across multiple regions simultaneously

+ Review and provide final approval Worldwide Marketing Applications, Clinical Study Reports, protocols, Investigator Brochures before release from our Company to external agencies and investigators

+ Represent GRA within our Company's internal committees to provide regulatory advice and approval according to the committee charters (therapeutic area Document Review Committees (DRC), Product Development Team (PDT), Early Development Team (EDT), and Label Evaluation and Development team

+ Conducts initial IND/CSA content review and approval to facilitate initial approval by agencies for conduct of clinical trials.

+ Participate in regulatory due diligence activities for licensing candidate review

**Minimum Education & Experience Requirements:**

+ Degree in biological science or related discipline

+ B.S., with minimum of 7 years of relevant drug development experience

+ M.S. with minimum of 5 years relevant drug development experience

+ M.D. with minimum of 3 years relevant drug development experience or clinical experience

+ PhD/PharmD with minimum of 5 years relevant drug development experience

**Required Experience:**

+ Ability to achieve optimal results with limited day-to-day direction from Therapeutic Area Lead

**Preferred Experience:**

+ Experience with immunology, neuroscience and/or ophthalmology development programs

+ Small and large molecule experience

+ Substantial experience in Regulatory Affairs

Current Employees apply HERE (

Current Contingent Workers apply HERE (

**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 ( 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 (

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 anothers thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts (

**U.S. Hybrid Work Model**

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote.

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidates relevant skills, experience, and education.

Expected US salary range:

$169,700.00 - $267,200.00

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here ( .

**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

**Required Skills:**

Communication, Compliance Programs, Cross-Functional Teamwork, Drug Development, Economic Impact Analysis, Global Regulatory, Regulatory Affairs Management, Regulatory Approvals, Regulatory Communications, Regulatory Filings, Regulatory Strategies, Regulatory Submissions, Regulatory Training, Social Collaboration, Strategic Planning, Strategic Thinking

**Preferred Skills:**

**Job Posting End Date:**

06/10/2025

***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:** R350679