(Senior) Manager, International Public Policy and Regulatory Affairs (1078-679)

4 days left

Location
Rockville, Maryland, United States
Posted
Apr 04, 2018
Closes
Apr 27, 2018
Function
Management
Hours
Full Time

This new role supports a vital USP function of managing key country regulatory engagement and supporting regulatory policy and landscape analysis needs of Program Unit Teams and global sites; and overseeing targeted research topics as identified by Program Unit and Country Planning teams. The incumbent in this role also participates in country teams or regional strategy sessions, advising and assisting with strategic planning and execution of activities related to the regulatory policy of a country/region, and develops strong working relationship with partners to meet USP’s winning ambition of advocating for the use of standards by supporting the strengthening their regulatory systems while advancing the use of USP and other pharmacopeial standards in these countries.

Roles and Responsibilities:

  • Supports Senior Director, Country and Regional Engagement, in managing of functional team.
  • Manages key country public policy and regulatory portfolio, including Memorandum of Understanding, scientific collaboration and regulatory trends analysis.
  • Works closely with Program Unit Teams and global sites to support ongoing monitoring as well as in-depth analysis of the policy and regulatory environment.
  • Liaises with Strategy, Marketing and Intelligence and Analysis and engages in collaborative projects as relevant.
  • Develops project management processes and system to ensure information reaches key internal stakeholders in a timely and relevant way.
  • Initiates partnerships with entities and/or vendors, as needed, to ensure delivery of analysis and information to internal stakeholders.

 

Basic Qualifications:

 Manager

  • Bachelor’s degree in public health, science, politics, law or other relevant field.
  • Minimum of five (5) years of significant experience working in government affairs, public policy and/or regulatory affairs.
  • Minimum of one (1) year of experience at the manager level.         
  • Demonstrated progression in career with increasing responsibilities, including building relationships with key stakeholders, in an external affairs function either in the life sciences industry, healthcare-focused non-governmental, multi-lateral organization, healthcare trade association, or in a public sector health institution.

Senior Manager

  • Bachelor’s degree in public health, science, politics, law or other relevant field.
  • Minimum of eight (8) years of significant experience working in government affairs, public policy and/or regulatory affairs.
  • Minimum of two (2) years of experience at the manager level.       
  • Demonstrated progression in career with increasing responsibilities, including building relationships with key stakeholders, in an external affairs function either in the life sciences industry, healthcare-focused non-governmental, multi-lateral organization, healthcare trade association, or in a public sector health institution.

 

 Preferred Qualifications

 

  • Master’s degree in public health, science, politics, law or other relevant field.
  • Prior experience in a scientific based industry.
  • Knowledge and understanding of health ministries, pharmacopeias, other government agencies, regulatory frameworks, as well as relevant policy trends in key countries.
  • Understanding of USP standards-setting processes and compendial terminology.
  • Strong regulatory and policy analysis skills.
  • Knowledge of language(s) and cultural sensitivities.
  • Ability and desire to work well with diverse employees and partners in a cooperative and constructive manner.
  • Advanced knowledge of general management and leadership principles.
  • Ability to influence others without direct authority.
  • Strong team building skills in the management of cross-functional teams.
  • Strong critical thinking and problem solving skills.
  • Excellent written and verbal communications skills.
  • Excellent facilitation, presentation, and reporting skills.
  • Ability to handle multiple priorities in a fast-paced environment.
  • Strong understanding of project planning and project management.
  • Strong time management and organizational skills, and attention to detail.
  • Ability to travel to support intl. public policy and regulatory affairs engagements.
  • Advanced computer competence (MS Office programs, e-mail and workflow systems).

USP offers an impressive benefits package, including:

  • Generous paid time off – 13 paid holidays, 10 sick days and 15 vacation days per year to start
  • An annual 401(k) contribution, beginning after 1 year of service, of 10% of pay (base and bonus) every pay period that vests immediately
  • Comprehensive individual and family healthcare plans with affordable premiums and low annual deductibles ($250/individual or $500/family)

The U.S. 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. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries.

Being a part of USP means belonging to a diverse culture made up of more than 1,000 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 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP. 

Job Location Rockville, Maryland, United States Position Type Full-Time/Regular

Similar jobs