U.S. Pharmacopeial Convention Jobs

Job Information

The U.S. Pharmacopeial Convention (USP) Senior Public Policy & Regulatory Affairs Manager –EMEA in Basel, Switzerland

Description

The Senior Public Policy and Regulatory Affairs Manager - EMEA, will share our vision of better quality health for everyone and is driven by the opportunity to make an impact. This professional will be responsible for working collaboratively across the USP EMEA 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. 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. This position is based in USP Basel Office or potentially also home based in a suitable EMEA country.

Roles and Responsibilities

The role will be instrumental to support the EMEA team and the Global GEA function to achieve the primary mission goals of the organization and will serve as a primary contact point for all GEA matters relevant for the EMEA region.

Regulatory Affairs

  • This leader will serve as the key USP relationship manager with regulatory and government stakeholders in the region, partnering with and leveraging USP internal resources globally to advance science and policy-based collaboration opportunities. S/he will be an advocate for regulatory policy initiatives to advance quality. In addition, s/he will 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 the EMEA region. 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

  • This 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. S/he 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 manager with other key stakeholders in the region, such as professional, trade and patient associations. Map and prioritize, building, executing and maintaining long-lasting relationships.

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 the EMEA region, contribute insight into global strategy development and sharing best practice with USP colleagues in other geographies.

Basic Qualifications

  • Master’s degree in public health, science, politics, law or other relevant field.

  • Eight (8) years of progressively responsible and significant experience working in regulatory and/or public policy in the EMEA region or in parts of EMEA with significant cross-country and cross-cultural exposure.

  • Five (5) years professional experience working in EMEA 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.

Preferred Qualifications

  • 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, Arabic language skills strongly preferred, French an additional advantage. Possessing also Russian language skills would be ideal.

  • Availability to travel across the EMEA region (40% - 50%).

Job Category Ext. Affairs, Regulatory, & Communications

Job Type Full-Time

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