Global Programs Director, Regulatory & Lab Growth

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

Job summary

The Senior Director, Global Programs (Regulatory and Laboratory) at USP leads the global growth strategy for externally funded regulatory and laboratory programs, partnering with funders and internal teams to shape opportunities in the United States and internationally.

You will supervise a global team, represent USP as a thought leader, and advance regulatory excellence across NRAs, pharmacovigilance, post-market surveillance, and BE/BA studies, contributing to global health standards.

Qualifications

• Bachelor's or advanced degree in scientific, regulatory or related field.
• Minimum of five (5) years’ experience in regulatory role with stringent authorities.
• Minimum of ten (10) years’ experience in Good Practice guidelines and regulations in pharmaceuticals/biologics (GxPs).
• Experience with/w 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.
• Willingness/ability to travel at least 25% domestically and internationally.
• Proven track record of thought leadership through speaking engagements/panels/publications.

Responsibilities

• Develop and adjust USP’s growth strategy for regulatory and laboratory programming.
• Interface with external and internal stakeholders, including funders, to align opportunities with needs.
• Align USP offerings to customer needs and develop new offerings in regulatory and laboratory space.
• Represent USP externally as a thought leader in technical discussions and forums.
• Provide technical input to funding proposals and lead proposal development.
• Manage and deploy a global team to support growth strategy and implementation.
• Oversee funded programming including regulatory strategies, NRAs, PV, post-market surveillance, BE/BA trials.
• Collaborate with GHMS leaders to advance USP’s mission.
• Other duties as assigned.

Skills

Regulatory leadership

Global program management

Stakeholder engagement

Thought leadership

Fundraising partnerships

Project management

Education

Bachelor's or advanced degree in scientific/regulatory field

Job description

The Senior Director, Global Programs (Regulatory and Laboratory) at USP leads the global growth strategy for externally funded regulatory and laboratory programs, partnering with funders and internal teams to shape opportunities in the United States and internationally.

You will supervise a global team, represent USP as a thought leader, and advance regulatory excellence across NRAs, pharmacovigilance, post-market surveillance, and BE/BA studies, contributing to global health standards.