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

Merck; Boston (MA); Hybrid; USD 180.000 - 240.000; Vollzeit

Zusammenfassung

Merck & Co., Inc. in the United States is seeking a Senior Principal Scientist, Regulatory Affairs Liaison to lead worldwide regulatory strategy for General Medicine programs, with focus on cardiovascular/metabolic development. The role emphasizes independence, strategic oversight, and interactions with global agencies to optimize labeling and time-to-approval across multiple regions. Hybrid work arrangement is offered.

Qualifikationen

• Degree in biological science or related discipline.
• Clinical reporting and regulatory affairs experience preferred.
• Experience leading regulatory strategy for drug development programs.

Aufgaben

• Oversee global regulatory strategy development for cardiovascular metabolic programs.
• Lead the Global Regulatory Team coordinating cross-functional regulatory support.
• Interface with FDA and global agencies to optimize labeling and approval timelines.
• Review/approve study protocols and regulatory submissions as needed.
• Represent the company in regulatory discussions across multiple regions.

Kenntnisse

Biological Sciences

Clinical Reporting

Drug Development

Global Health

Regulatory Affairs

Regulatory Strategy

Written Communication

Regulatory Compliance

Regulatory Issues

Regulatory Strategies

Product Approvals

Ausbildung

B.S. in Biological Science

M.S. in Biological Science

M.D.

Ph.D./PharmD

Jobbeschreibung

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.

Senior Principal Scientist, Regulatory Affairs Liaison

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

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

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

Domestic

VISA Sponsorship

No

Travel Requirements

10%

Flexible Work Arrangements

Hybrid

Shift

Not Indicated

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.