Merck Merck Jobs in Reston, VA (NOW HIRING)

Job Description Overview

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.

Primary Responsibilities

• 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 Qualifications

• 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

Salary and Benefits

Salary Range: $190,800.00 – $300,300.00 (established at the time of posting). The successful candidate will be eligible for annual bonus and long‑term incentive, if applicable. Benefits include medical, dental, vision, retirement, 401(k) match, paid holidays, vacation, and compassionate and sick days. More information is available on our compensation and benefits page.

Location Requirements

San Francisco Residents Only – The company will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance.

Los Angeles Residents Only – The company will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.

Travel Requirements

10% outside of the immediate office location.

Flexible Work Arrangements

Hybrid – Combination of in‑office and remote work.

EEO Statement

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.