Principal Scientist, Regulatory Liaison - Immunology

Job Description

The Director (Principal Scientist), Global Regulatory Liaison reports to the Executive Director, General Medicine and is responsible for development and implementation of worldwide regulatory strategies for their assigned projects within the Immunology Therapeutic Area. The individual provides regulatory oversight for assigned products, to optimize product labeling and obtain shortest time to approval by global regulatory agencies.

The Global Regulatory Liaison is expected to independently manage projects, functioning as the single, accountable, global point of contact on those project teams and interact with Worldwide Regulatory Agencies and/or subsidiaries regarding global regulatory strategy/registration requirements for one or more company investigational and marketed drugs/biologics. This position requires a leader who is proactive, self motivated, and who can manage complex programs that may involve multiple indications, formulations, or external partners with direction from the Executive Director. Experience in immunology strongly preferred.

Key Functions

• •Develops worldwide product regulatory strategies to optimize labeling and obtain shortest time to approval by regulatory agencies for assigned indications
• •Assesses regulatory/competitive landscape to establish global regulatory strategies that facilitate speed-to-market and the delivery of targeted product labeling
• •Provides 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
• •Provides leadership to the Global Regulatory Team which coordinates cross-functional regulatory support for development programs and marketed products
• •Coordinates the preparation, submission and follow-up contact with regulatory agencies and/or subsidiaries for all applications and submissions and responsible for regulatory review and final approval for all submissions and associated documentation.
• •Reviews and provides final approval of local registration study protocols when needed to obtain marketing authorization in secondary markets
• •Interact independently with regulatory agencies (FDA, EMA, etc.), including leading meetings, teleconferences, and written communications
• •Coordinate regional regulatory strategy and submissions through collaboration with Regulatory Affairs Europe (RAE) and local affiliate teams.
• •Reviews Worldwide Marketing Applications, Clinical Study Reports, protocols, Investigator Brochures
• •Prepares IND/CTAs for global studies related to investigational drugs/biologics
• •Participates in regulatory due diligence activities for licensing candidate reviews

Minimum Education & Experience Requirements:

• •B.S. or M.S with a minimum of 7 years of relevant drug development experience with majority in regulatory or
• •M.D. or PhD/PharmD with a minimum of 5 years relevant drug development experience with three years in regulatory

Required Experience:

Strong strategic thinking, problem-solving, and continuous learning mindset.

Effective communicator—both written and verbal—with the ability to influence, lead, and negotiate across levels and functions.

Experience leading or supporting direct interactions with major Health Authorities (e.g., FDA, EMA).

Demonstrated expertise in leading regulatory filings across global regions.

Preferred Experience:

Therapeutic area expertise in immunology

Small and large molecule experience

regulatory affairs experience in major markets (U.S., EU, Japan, China).

Required Skills:

Drug Development, Global Regulatory, Pharmaceutical Industry, Pharmaceutical Research, Product Registrations, Regulatory Affairs Management, Regulatory Communications, Regulatory Processes, Regulatory Strategies, Regulatory Submissions, Strategic Leadership

Preferred Skills:

Immunology

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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:

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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.

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The salary range for this role is

$173,200.00 - $272,600.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this 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 .

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End D