31 oct
|
USP
|
Ciudad de México
31 oct
USP
Ciudad de México
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. 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 general health. USP is proud to be an equal employment opportunity employer (EEOE) and is committed to ensuring fair, merit-based selection processes that enable the best scientific minds—regardless of background—to contribute to advancing public health solutions worldwide. We provide reasonable accommodations to individuals with disabilities and uphold policies that create an inclusive and collaborative work environment. 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
- Develop a landscape analysis of the opportunities and barriers for the manufacture of Active Pharmaceutical Ingredients (APIs)
for the United States market in Mexico. This includes:
- High-level assessment of the current state of preparedness of Mexican pharmaceutical industry to manufacture APIs for the United States.
- Key quality gaps that would need to be addressed, including compliance with USP standards.
- Policy incentives that could facilitate and/or accelerate the manufacture of APIs in Mexico for the US market.
- Current policy barriers to expanded and accelerating the manufacture of APIs in Mexico for the US market, including:
- US policy barriers.
- Mexico policy barriers.
- Policy incentives that could facilitate and/or accelerate the manufacture of APIs in Mexico for the US market, including:
- US policy incentives.
- Mexico policy incentives.
- 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:
- Stakeholder map and engagement plan.
- Key message points.
- Support, as directed, USP advocacy related to reliance on USP standards as part of the US-Mexico-Canada Agreement (USMCA). LATAM Regulators Week
- 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.
- 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 inf
📌 Senior Advisor, Policy (Ciudad de México)
🏢 USP
📍 Ciudad de México