Global Regulatory & Lab Programs Director

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

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.