Global Programs Director, Regulatory & Laboratory Growth

USP Brand; Rockville (MD); On-site; USD 208,000 - 262,000; Full time

Job summary

USP is seeking a Senior Director, Global Programs (Regulatory and Laboratory) to lead a global growth strategy for externally funded regulatory and laboratory programs. The incumbent will build long-term strategic relationships with funders and partners and supervise a global team across Africa and Asia.

As a visible external thought leader, you will shape proposals, align USP offerings to customer needs, and guide complex regulatory and BE/BA initiatives to strengthen public health outcomes

Qualifications

• Bachelor's or advanced degree in scientific, regulatory or related field.
• Minimum 5 years' experience in regulatory role within or interfacing with stringent regulatory authority/authorities.
• Minimum 10 years' experience in Good Practice guidelines and regulations in pharmaceuticals and/or biologics (GxPs).
• Experience with/understanding of WHO regulatory processes.
• Minimum 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.

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.

Skills

Regulatory leadership

Stakeholder engagement

Thought leadership

People management

Global/intl experience

Travel willingness

Education

Bachelor's or higher in scientific/regulatory field

Job description

USP is seeking a Senior Director, Global Programs (Regulatory and Laboratory) to lead a global growth strategy for externally funded regulatory and laboratory programs. The incumbent will build long-term strategic relationships with funders and partners and supervise a global team across Africa and Asia.

As a visible external thought leader, you will shape proposals, align USP offerings to customer needs, and guide complex regulatory and BE/BA initiatives to strengthen public health outcomes