Senior Advisor, Policy & Regulatory Affairs (LATAM)

Description

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.

Who is USP?

At USP, we value inclusive scientific collaboration and recognize that attracting diverse expertise strengthens our ability to develop trusted public health standards. We foster an organizational culture that supports equitable access to mentorship, professional development, and leadership opportunities. Our partnerships, standards, and research reflect our belief that ensuring broad participation in scientific leadership results in stronger, more impactful outcomes for global health.

Brief Job Overview

This fixed-term role will develop an analysis of the opportunities for and barriers to the manufacture of Active Pharmaceutical Ingredients (APIs) in Mexico for the United States market, and an associated advocacy plan for the removal of barriers and identification of policy incentives. The role will also develop and execute a “LATAM Regulators Week” in USP’s Rockville office with the goal to strengthen our engagements with key regulators in the region and increase their understanding and utilization of USP solutions to meet their goals in ensuring access to quality medicines.

This is a temporary role for 6 months.

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.

Additionally, USP’s People and Culture division, in partnership with the Equity Office, invests in leadership and workforce development to equip all employees with the skills to create high-performing, inclusive teams. This includes training in equitable management practices and tools to promote engaged, collaborative, and results-driven work environments.

The Senior Advisor – Policy & Regulatory Affairs (LATAM) has the following responsibilities:

Mexico Near-Shoring and USMCA

1. Develop a landscape analysis of the opportunities and barriers for the manufacture of Active Pharmaceutical Ingredients (APIs) for the United States market in Mexico.
2. High-level assessment of the current state of preparedness of Mexican pharmaceutical industry to manufacture APIs for the United States.
3. Key quality gaps that would need to be addressed, including compliance with USP standards.
4. Policy incentives that could facilitate and/or accelerate the manufacture of APIs in Mexico for the US market.
5. Current policy barriers to expanded and accelerating the manufacture of APIs in Mexico for the US market, including:
6. US policy barriers.
7. Mexico policy barriers.
8. Policy incentives that could facilitate and/or accelerate the manufacture of APIs in Mexico for the US market, including:
9. US policy incentives.
10. Mexico policy incentives.
11. Development of an advocacy plan, spanning Mexico and the US centered on removing policy barriers and creating policy incentives for the manufacture in Mexico of APIs for the US market. This should include:
12. Stakeholder map and engagement plan.
13. Key message points.
14. Support, as directed, USP advocacy related to reliance on USP standards as part of the US-Mexico-Canada Agreement (USMCA).

LATAM Regulators Week

1. Develop and execute, in collaboration with USP Rockville staff, a “LATAM Regulatory Week” program. Key audience members include reports to Heads of Agencies at four to six (4-6) National Regulatory Agencies in LATAM.
2. Objectives include: (i) Demonstrate the scale, credibility, and global impact of USP through on-site engagement; (ii) Align USP scientific perspectives with the regulatory priorities of LATAM NRAs; (iii) Strengthen relationships with senior regulatory decision-makers, creating a foundation for sustained engagement, future collaboration, and policy influence; and (iv) Provide regulators with practical tools and resources that support higher standards enforcement in their daily interactions with industry.
3. Target timing is 2Q – 3Q FY27 (4Q CY 26 – 1Q CY 27).

Who is USP Looking For?

The successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with stakeholders, along with the following competencies and experience:

• Bachelor’s degree in public health, science, politics, law or another relevant field.
• At least eight years of progressively responsible and significant experience working in regulatory and/or public policy in Mexico and/or LATAM Region.
• At least five years professional experience working in Mexico and/or LATAM Region building and fortifying relationships with key stakeholders, in an external affairs function either in the pharmaceutical or medical technology industries, a large healthcare-focused non-governmental or multi-lateral organization, a healthcare trade association, or in a public-sector health science institution.
• Demonstrated experience working within or interacting with government policy and/or regulatory bodies on scientific and regulatory policy topics.
• Demonstrated success working in a global, matrixed organization.

Additional Desired Preferences

• Familiarity with USP mission, offerings and stakeholders.

Supervisory Responsibilities

None, this is an individual contributor role.

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.

Job Category

Ext. Affairs, Regulatory, & Communications

Job Type

Full-Time