Sr. Principal Scientist (Sr. Director) - Regulatory Liaison

Merck; North Wales (Montgomery County); Ibrido; USD 191.000 - 300.000; Tempo pieno

Descrizione del lavoro

Merck in Rahway, NJ seeks a Senior Principal Scientist, Regulatory Affairs Liaison to lead worldwide regulatory strategy for General Medicine programs focused on cardiovascular metabolic areas. You will ensure optimal labeling and the fastest time to approval by engaging with FDA and other agencies across multiple indications.

This role requires a track record of leading global regulatory teams, strategic oversight across regions, and the ability to navigate complex regulatory environments with

Competenze

• Degree in biological science or related discipline.
• Regulatory affairs experience across multiple programs and life cycles.
• Strong leadership and team-building abilities.

Mansioni

• Develop worldwide regulatory strategy for General Medicine programs.
• Lead Global Regulatory Team and interact with FDA and other agencies.
• Coordinate regulatory submissions and labeling to optimize time to approval.
• Provide strategic regulatory oversight across regions and indications.
• Review study protocols and marketing applications for regulatory readiness.

Conoscenze

Regulatory Affairs

Drug Development

Regulatory Strategy

Written Communication

Product Approvals

Regulatory Compliance

Regulatory Leadership

Formazione

BS/MS/MD/PharmD in relevant field

Descrizione del lavoro

Job Description

Our Regulatory Affairs team in General Medicine advances medical innovation to patients by establishing clear, timely, and robust strategies for registration enabled by engagement with global health authorities. We work across functions and geographies to advance development programs and maintain licensure for the General Medicine portfolio worldwide. We seek a leader with a growth mindset, demonstrated by intellectual curiosity and the ability to navigate complex regulatory challenges with rigor and professionalism.

Our Regulatory Affairs team in General Medicine advances medical innovation to patients by establishing clear, timely, and robust strategies for registration enabled by engagement with global health authorities. We work across functions and geographies to advance development programs and maintain licensure for the General Medicine portfolio worldwide. We seek a leader with a growth mindset, demonstrated by intellectual curiosity and the ability to navigate complex regulatory challenges with rigor and professionalism. The Senior Principal Scientist, Regulatory Affairs Liaison is responsible for the development and implementation of worldwide regulatory strategy for programs in the General Medicine therapeutic area with specific focus on development programs in cardiovascular metabolic. The individual functions with a high degree of independence and provides strategic regulatory oversight for assigned programs to optimize labeling and obtain shortest time to approval by regulatory agencies. The individual should be adaptive to change and embrace entrepreneurship. The Senior Principal Scientist will independently manage assigned programs. As the Global Regulatory Lead (GRL), the Senior Principal Scientist functions as the regulatory single, accountable, global point of contact on the project team and interacts with the global regulatory agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or more company investigational and marketed drugs/biologics in early- and/or late-stage development. Programs may be complex with more than one indication, formulation or have an external business partner. In addition, the role may require periodic non-program assignments in General Medicine.

Primary Activities Include, But Are Not Limited To

• Report to Executive Director or Associate Vice President, General Medicine
• Oversee the global regulatory strategy development and execution for their assigned programs in the cardiovascular metabolic therapeutic area to optimize labeling and obtain shortest time to approval by regulatory agencies for multiple indications simultaneously
• Provide expert advice as the GRL to Early Development Teams (EDT)/Product Development Teams (PDT) and regulatory single point-of-contact for products within and external to Global Regulatory Affairs and Clinical Safety (GRACS) on regulatory issues as they arise with the developmental compounds or marketed products throughout the entire life cycle of the drug
• Provide leadership by leading the Global Regulatory Team (GRT) for assigned cardiovascular/renal/respiratory programs which coordinates global, 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
• Represent 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 teams for meetings with FDA at any phase of drug development
• Coordinate interactions with global regulatory agencies through Regulatory Affairs Europe, Regulatory Affairs International, 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 Global Regulatory Affairs within internal company committees to provide regulatory advice and approval according to the committee charters (including therapeutic area Document Review Committees, PDT, EDT, and label development team)
• Conduct 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 10 years relevant drug development experience, with a majority in regulatory affairs
• M.S. with minimum of 10 years relevant drug development experience, with a majority in regulatory affairs
• M.D. with minimum of 7 years relevant drug development experience, with 5 years in regulatory affairs
• PhD/PharmD with minimum of 7 years relevant drug development experience, with 5 years in regulatory affairs

Required

• Ability to achieve optimal results with limited day-to-day direction from the Therapeutic Area Lead
• Outstanding interpersonal, verbal and written communication, and negotiation skills.
• Demonstrated leadership attributes, including experience building and leading high-performing teams.

Preferred Experience

• Substantial experience with cardiovascular/renal/respiratory development programs, including pediatrics, orphan drug, and expedited development
• Substantial experience with both small and large molecule development programs
• Experience in regulatory affairs in global markets, such as EU, China, and Japan
• Prior GRL oversight of global regulatory submissions and approvals, including IND/CTAs and NDA/BLAs
• Knowledge and experience with devices (inhalers, auto injectors, pre-filled syringes, etc.)
• Proficient in AI applications (Co-pilot, Chat GPT, etc)

Required Skills

Biological Sciences, Clinical Reporting, Drug Development, Global Health, In Vitro Diagnostics (IVD), Multiple Therapeutic Areas, Pharmaceutical Regulatory Affairs, Process Improvements, Product Approvals, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance, Regulatory Issues, Regulatory Strategies, Regulatory Strategy Development, Written Communication

Employee Status

Regular

Relocation

Domestic

VISA Sponsorship

No

Travel Requirements

10%

Flexible Work Arrangements

Hybrid

Shift

Not Indicated

Valid Driving License

No

Hazardous Material(s)

n/a

Primary Location

USA - New Jersey - Rahway

Salary Range

$190,800.00 - $300,300.00

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.

Benefits

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

Job Posting End Date

10/27/2026

Requisition ID

R404833