Senior Director, Global Programs (Regulatory and Laboratory)

US Pharmacopeia; Rockville (MD); On-site; USD 208,060 - 262,150; Full time

Job summary

USP in Rockville, MD seeks a strategic leader to develop and implement a global growth strategy for externally funded regulatory and laboratory programs. You will build long-term relationships with funders and partners to expand programs in the U.S. and internationally while guiding a global team across continents.

The role emphasizes regulatory excellence, scientific integrity, and high-impact collaboration to strengthen public health standards and access to medicines worldwide.

Qualifications

• Bachelor's or advanced degree in scientific, regulatory or related field.
• Minimum of five years’ experience in regulatory role within or interfacing with stringent regulatory authority/authorities.
• Minimum of ten years’ experience in Good Practice guidelines and regulations in pharmaceuticals/biologics (GxPs).
• Experience with/understanding of WHO regulatory processes.
• Minimum of five years in roles with international scope.
• Minimum of seven to nine years of people management experience.
• Willingness to travel at least 25% domestically and internationally.

Responsibilities

• Develop and continuously adjust USP’s growth strategy for regulatory and laboratory programming.
• Interface with external and internal stakeholders to understand regulatory landscape and customer needs.
• Align USP offerings to meet needs and develop new offerings in regulatory and laboratory space.
• Represent USP externally as a thought leader in technical discussions and external forums.
• Provide input to funding proposals and lead development of proposals focused on growth.
• Manage and deploy a global team to support growth strategy and implementation of programs.
• Oversee funded programming with strategic oversight for regulatory strategies and pharmacovigilance.

Skills

Regulatory leadership

International program management

Thought leadership

Travel willingness

Education

Bachelor's or advanced degree in science/regulatory

Job description

Who is USP?

The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world’s leading health and science experts to develop rigorous quality standards for medicines, dietary supplements, and food ingredients. At USP, we believe that scientific excellence is driven by a commitment to fairness, integrity, and global collaboration. This belief is embedded in our core value of Passion for Quality and is demonstrated through the contributions of more than 1,300 professionals across twenty global locations, working to strengthen the supply of safe, high-quality medicines worldwide.

Brief Job Overview

This role, a critical member of the Global Health and Manufacturing Services (GHMS) leadership team, is responsible for developing and implementing a global growth strategy for USP’s externally funded regulatory and laboratory programs. The incumbent will be primarily responsible for developing long-term strategic relationships with potential funders and partners which drive towards shaping and ultimate realization of new opportunities for programming in the United States and internationally. Additionally, she/he will represent USP externally as a thought leader in a variety of forums and will supervise a global team across Africa and Asia.

How will YOU create impact here at USP?

As part of our mission to advance scientific rigor and public health standards, you will play a vital role in increasing global access to high-quality medicines through public standards and related programs. USP prioritizes scientific integrity, regulatory excellence, and evidence-based decision-making to ensure health systems worldwide can rely on strong, tested, and globally relevant quality standards.

Responsibilities

• Develop and continuously adjust USP’s growth strategy for regulatory and laboratory programming.
• Interface and partner with external and internal stakeholders, including potential funders, to understand evolving regulatory and laboratory technology landscape and customer needs.
• Align existing USP offerings and solutions to meet customer needs and develop new offerings in the regulatory and laboratory space to address gaps.
• Represent USP externally as a thought leader in technical discussions and in external forums to advance programming growth.
• Provide technical support and input to relevant funding proposals; and lead the develop of proposals with a primary focus on growing the regulatory and laboratory program.
• Manage and deploy global team to support growth strategy and implementation of secured programming.
• Support and/or oversee implementation of funded programming including providing strategic and technical oversight for specialized health systems programming, with a strong focus on regulatory strategies, strengthening National Regulatory Authorities (NRAs), pharmacovigilance (PV), post-market surveillance systems, and clinical study capacity for Bioequivalence/Bioavailability (BE/BA) trials.
• Be a thought partner to other leaders within the GHMS team as we collectively advance USP’s mission and broader strategic goals.
• Other duties as assigned.

Qualifications

• Bachelor's or advanced degree in scientific, regulatory or related field.
• Minimum of five (5) years’ experience in regulatory role within or interfacing with stringent regulatory authority/authorities.
• Minimum of often (10) years’ experience in Good Practice guidelines and regulations in pharmaceuticals and/or biologics (GxPs).
• Experience with/ understanding of WHO regulatory processes.
• Minimum of five (5) years in roles with international scope.
• Minimum of seven (7) to nine (9) years of people management experience.
• Proven track record of thought leadership as evidenced by speaking engagements/ panel roles and/or publications/ other content generation.
• Willingness/ ability to travel at least 25% domestically and internationally.

Additional Desired Preferences

• Demonstrated ability to design, manage, and implement complex projects.
• Active network with potential funding sources / entities, including global (such as Gates, Global Fund) and domestic funders (such as Department of War, Health and Human Services, etc.).
• Experience and/or exposure with the changing landscape of regulatory and laboratory science as applied to new manufacturing and quality modalities (e.g., advanced manufacturing, AI-enabled processes, non-destructive testing).
• Relevant work experience in a lower middle income country (LMIC).
• Experience working in program / project management or other relevant technical area in DARPA, BARDA, JPEO-CBRAND or similar.

Supervisory Responsibilities

• Director / Sr Manager, International regulatory and laboratory programs
• Senior Pharmacovigilance Manager
• Senior Technical Advisor

Benefits

USP provides the benefits to protect yourself and your family today and tomorrow. From company-paid time off and comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial well-being is protected.

Compensation

Base Salary Range: USD $208,060.00 – $262,150.00 annually.
Target Annual Bonus: % Varies based on level of role.
Individual compensation packages are based on various factors unique to each candidate’s skill set, experience, qualifications, equity, and other job-related reasons.

Note: USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP.

Equal Opportunity Employer

This employer is required to notify all applicants of their rights pursuant to federal employment laws.
For further information, please review the Know Your Rights (https://www.eeoc.gov/poster) notice from the Department of Labor.

Job Category

Ext. Affairs, Regulatory, & Communications

Job Type

Full-Time