Senior Manager/Manager, Public Policy and Regulatory Affairs - Latin America

Employer
US Pharmacopeia
Location
Rockville, MD
Posted
Oct 12, 2017
Closes
Oct 16, 2017
Function
Management
Hours
Full Time
The Senior Manager Public Policy and Regulatory Affairs a Latin America will be responsible for working collaboratively across Latin America the Caribbean LAC countries and USP Global External Affairs Division to build and execute a public policy and regulatory affairs plan to advance USPa s mission and strategic goals in the region This critical and key 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 collaborative initiatives with them that advocate for and advance medicines quality contributing to USPa s public health impact Roles and Responsibilities Regulatory Affairs a Provide organization with insights into and analysis of regulatory developments related to medicines and other applied programs such as dietary supplements and foods from key government agencies Serve as a key USP relationship manager with regulatory and government stakeholders in the region partnering with and leveraging USP internal resources globally to advance collaboration opportunities Identify monitor and communicate key regulatory initiatives and policy trends 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 a Provide organization with insight 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 a Map and prioritize other key stakeholders in the region such as professional associations building executing and maintaining long lasting relationships Advocacy for Quality a Participate in relevant national and regional fora to advocate for quality and patient safety USP Global Public Policy and Regulatory Team a Serve as a member of the USP Global Public Policy and Regulatory Team providing input related to Latin America Caribbean countries and sharing best practice with USP colleagues in other geographies Basic Qualifications For Sr Manager Bachelora s degree in public health science politics law or other relevant field At least years of progressively responsible and significant experience working in Government Affairs Public Policy and or Regulatory Affairs in the LAC region At least three years professional experience working in LAC at a leadership and strategic level building and fortifying key relationships with key stakeholders in an external affairs function either in the life sciences medical technology industry large healthcare focused non governmental multi lateral organization healthcare trade association or in a public sector health institution Demonstrated experience working within or interacting with government policy and or regulatory bodies For Manager Bachelora s degree in public health science politics law or other relevant field At least years of progressively responsible and significant experience working in Government Affairs Public Policy and or Regulatory Affairs in the LAC region At least two years professional experience working in LAC at a leadership level building and fortifying key relationships with key stakeholders in an external affairs function either in the life sciences medical technology industry large healthcare focused non governmental multi lateral organization healthcare trade association or in a public sector health institution Demonstrated experience working within or interacting with government policy and or regulatory bodies Preferred Qualifications Advanced degree in public health science politics law or other 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 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 Ability to speak fluent English and Spanish required Ability to travel of the time required USP offers an impressive benefits package including Generous paid time off a paid holidays sick days and vacation days per year to start An annual k contribution beginning after year of service of of pay base and bonus every pay period that vests immediately Comprehensive individual and family healthcare plans with affordable premiums and low annual deductibles individual or family The US Pharmacopeial Convention USP is a scientific nonprofit organization that sets standards for the identity strength quality and purity of medicines food ingredients and dietary supplements manufactured distributed and consumed worldwide USPa s drug standards are enforceable in the United States by the Food and Drug Administration and these standards are used in more than countries Being a part of USP means belonging to a diverse culture made up of more than talented professionals working together at five international locations We share our expertise in science IT human resources quality assurance communications administrative management and more all to support an overall mission dedicated to making a difference by providing standards and programs that help improve the quality of medicines dietary supplements and foods worldwide USP is proud to be an equal employment opportunity employer EEOE and affirmative action employer Employment selection and related decisions are made without regard to sex race age disability religion national origin color veteran status sexual orientation gender identity or any other protected class We are committed to working with and providing reasonable accommodation to individuals with disabilities USP does not accept unsolicited resumes from rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP Required Skills Required Experience Job Location Rockville MD