Principal Scientist, Regulatory Liaison

Merck; Rahway (NJ); Hybrid; USD 173,200 - 272,600; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Comprehensive benefits

Job summary

Merck in Rahway, NJ is seeking a Regulatory Affairs Headquarters Principal Scientist to lead global regulatory strategy for vaccines and infectious diseases. You will serve as the primary regulatory contact across GRACS and external partners, shaping development plans and regulatory submissions.

The role requires advanced degrees and substantial drug development or clinical experience, with strong communication and leadership skills.

Qualifications

• MD or PhD with regulatory experience or equivalent.
• 3+ years of drug development or clinical experience (PhD: 5 years; MS: 7 years, regulatory preferred).
• Excellent oral and written communication skills.
• Strong organizational skills with ability to multi-task across projects.

Responsibilities

• Regulatory oversight for assigned products as global regulatory contact within GRACS.
• Develop worldwide regulatory strategy to optimize labeling and time to approval.
• Advise development teams on regulatory issues throughout the lifecycle of the product.
• Provide leadership as head of the Global Regulatory Team coordinating cross-functional regulatory support.
• Represent company with FDA, chair FDA meetings, and prepare teams for meetings with FDA.
• Lead cross-functional efforts for advisory committee preparation and potential participation.
• Coordinate interactions with foreign agencies to support regulatory strategy across regions.
• Review and approve Worldwide Marketing Applications, CSRs, Protocols, and Investigators Brochures.
• Participate in internal committees to provide regulatory guidance and approvals.
• IND/Clinical Study Agreement content review to facilitate trials and regulatory filings.
• Support regulatory due diligence for licensing candidates and BD partnerships.

Skills

Communication skills

Organizational skills

Flexibility

Scientific/analytical skills

Independent work

Education

MD or PhD or related doctoral degree in biological sciences, chemistry or related discipline

Job description

Job Description

The Regulatory Affairs Headquarters Principal Scientist is responsible for development and implementation of global regulatory strategy for their assigned projects in the Vaccines and Infectious Disease therapeutic area.

The Regulatory Affairs Headquarters Principal Scientist is responsible for development and implementation of global regulatory strategy for their assigned projects in the Vaccines and Infectious Disease therapeutic area.

Primary Activities Include, But Are Not Limited To

• Functions with a high degree of independence and provides regulatory oversight for assigned products, functioning as the single, accountable, global regulatory point of contact on those projects within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.
• Develops worldwide product regulatory strategy to optimize label and obtain shortest time to approval by regulatory agencies for multiple indications simultaneously.
• Provides expert advice to Product Development Teams and subsidiaries on regulatory issues as they arise with the developmental compounds or marketed products throughout the entire life cycle of the drug.
• Provides leadership as head of the Global Regulatory Team, which coordinates cross-functional regulatory support for development programs and marketed products.
• Represents our company with external organizations through direct communication with the FDA, including telephone calls and e-mail; chairs meetings between our company and FDA; prepares our company teams for meetings with FDA at all phases of drug development.
• Leads cross-functional efforts to prepare for advisory committees and may speak at the advisory committee.
• Coordinates 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.
• Reviews and provides final approval of Worldwide Marketing Applications, Clinical Study Reports, Protocols, Investigators Brochures before release from our company to external agencies and investigators.
• Represents Global Regulatory Affairs (GR) within internal committees to provide regulatory advice and approval according to the committee charters (therapeutic area Document Review Committees, Product Development Team, Early Development Team, and Label Evaluation and Development Team.
• Conducts initial Investigational New Drug application/Clinical Study Agreement content review and approval to facilitate initial approval by regulatory agencies for conduct of clinical trials.
• Participates in regulatory due diligence activities for licensing candidate review and works with business development partners in executing regulatory responsibilities to advance developmental compounds or support marketed products.

Global Regulatory Affairs and Clinical Safety

500

Additional Locations:

USA-New Jersey-Rahway

USA-Pennsylvania-Philadelphia-WeWork

10%

Education Minimum Requirements

• M.D. or Ph.D. or other related doctoral degree in biological science, chemistry or related discipline. Other degrees such as master's with substantial experience in regulatory affairs to suggest equivalent ability to function in this position.

Required Experience And Skills

• M.D. with minimum of 3 years relevant drug development or clinical experience required, or
• Ph.D. with minimum of 5 years relevant drug development experience required, or
• M.S. with minimum of 7 years relevant drug development or clinical experience, preference if this experience is in regulatory affairs.
• Excellent communication skills (both oral and written).
• Good organizational skills with a proven ability to simultaneously balance activities or multiple projects.
• Flexibility required.
• Strong scientific and analytical skills with attention to detail.
• Ability to achieve optimal results with limited day-to-day direction from the manager.

Preferred Experience And Skills

• Substantial experience in regulatory affairs.
• Therapeutic area experience in vaccines or infectious diseases. Experience with antibacterial, antifungal or antiviral agents.

Vaccines and Infectious Diseases

Global Regulatory Affairs

Individual Contributor

Global

Adaptability, Cross-Functional Collaboration, Drug Development, Exercises Judgment, Infectious Disease, Pharmaceutical Regulatory Affairs, Process Improvements, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Communications, Regulatory Issues, Regulatory Reporting, Regulatory Strategy Development, Regulatory Submissions, Strategic Thinking

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.

Requirements

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 another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts

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

Employee Status

Regular

Relocation

Domestic

VISA Sponsorship

No

Travel Requirements

10%

Flexible Work Arrangements

Hybrid

Shift

1st - Day

Valid Driving License

No

Hazardous Material(s)

N/A

Job Posting End Date

• 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:

R408715

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.