The U.S. Pharmacopeial Convention (USP) Associate Government & Regulatory Affairs Director in Barueri-SP, Brazil
Who is USP?
The U.S. Pharmacopeial Convention (USP) USP is an independent scientific organization that collaborates with the world's top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP's fundamental belief that Equity = Excellence manifests in our core value of Passion for Quality through our more than 1,100 talented professionals across five global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide.
Brief Job Overview
The Government and Regulatory Affairs Associated Director – LATAM, will share our vision of betterquality health for everyone and is driven by the opportunity to make a public health impact within the Region. The role will be responsible for working collaboratively across the USP LATAM Region and USP Global External Affairs Division to build and execute a public policy and regulatory affairs plan to advance USP’s public health mission in Brazil, Chile, and Peru. This role has responsibility over several external affairs’ functional areas, with a primary focus on government and regulatory affairs. In addition, this role will have responsibility for building and fortifying key relationships with other priority stakeholders, seeking to develop and execute scientific, regulatory policy and other collaborative initiatives with them that advance medicines quality as well as the quality of dietary supplements.
How will YOU create impact here at USP?
• Regulatory Affair s – This USP leader will serve as the key USP relationship representative with regulatory and government stakeholders in Brazil, Chile, and Peru, partnering with and leveraging USP internal resources to advance science and policy-based collaboration opportunities. This leader will be an advocate for regulatory policy initiatives to advance quality. In addition, they will identify collaborative opportunities and provide the USP organization with insights into, and
analysis of, regulatory developments related to medicines and other applied programs, such as dietary supplements from key government agencies within Brazil, Chile, and Peru. Develop Regulatory Intelligence program identifying, monitoring, and communicating key regulatory initiatives and policy trends. Stablish, build, and execute MoU’s with Regulatory Agencies and other Stakeholders properly and in accordance with USP internal policy and guidance. Engage USP leadership and staff on those trends and work with them to analyze their impact on USP programs and strategies and craft and execute constructive responses.
• Public Policy/Government Affairs – This USP leader will identify and understand public policy developments that impact medicine quality and leverage opportunities to shape policy through engagement with decision makers and through participation in relevant national and regional forums to advocate for quality and patient safety. This work will be enabled by leveraging USP’s global network of science and health policy experts. They will also provide the organization with insights into government policy priorities related to medicines access and quality and other applied programs, build collaborative relationships with key public-sector stakeholders, and seek partnership opportunities. Map and prioritize stakeholders and influencers and build and execute
engagement plan. Collaborate with other USP experts in support of plan execution.
• Other Stakeholder Engagement – Be the lead engagement USP’s representative with other key stakeholders in the region, such as professional, trade and patient associations. Map and prioritize, building, executing, and maintaining long-lasting relationships. Be the lead of Regional Chapter initiatives and USP Convention Members and Volunteers relationship within the Region.
• USP Global Public Policy and Regulatory Team – Serve as a member of the USP Global Public Policy and Regulatory Affairs Team providing input related to LATAM Region, contribute insight into global strategy development and sharing best practice with USP colleagues in other
Who USP is 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, politics, law, pharmaceutical sciences, chemistry, or another relevant field related to health.
• At least 5 years of progressively responsible and significant experience working with regulatory agency in Brazil.
• Professional experience working in Brazil 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.
• At least five years in leadership positions.
• 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
• Advanced degree in public health, politics, law, pharmaceutical sciences, chemistry, or another relevant field.
• Strong knowledge of regulatory environment and other government bodies.
• Knowledge of the life sciences industry especially in areas of regulatory affairs, public policy, and product quality.
• Strong policy analysis skills.
• Strategic thinking, strong written and verbal communication skills.
• Leadership skills.
• Self-motivated and proactive with a sense of urgency, with proven ability to prioritize and focus on key objectives.
• Proven aptitude for building relationships, credibility, and trust with stakeholders, and creating a collaborative work environment.
• Ability to influence without direct authority.
• Solution-oriented and innovative; can identify creative options for resolving issues that respond to multiple stakeholder interests and needs.
• Proficiency in English. Advanced in Spanish.
• Availability to travel across the LATAM Region (30 %).
USP provides you with the benefits you need to protect yourself and your family today and tomorrow. From company-paid time off, comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial wellbeing is protected.
COVID-19 Vaccination Policy (will apply to the selected candidate(s) hired):
USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. We are committed to creating an inclusive environment in all aspects of our work—from the standards we make to the partnerships and conversations we cultivate. An environment where every employee feels fully empowered and valued irrespective of, but not limited to, personality, race, ethnicity, physical and mental abilities, education, religion, gender identity and expression, life experience, sexual orientation, country of origin, regional differences, work experience, and family status. We are committed to working with and providing reasonable accommodation to individuals with disabilities.
Note : USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP
Job Category Ext. Affairs, Regulatory, & Communications
Job Type Full-Time