Summary of the Position
The U.S. Regulatory Advocacy Director will be responsible for building and executing a substantive engagement plan with stakeholder organizations and communities relevant to specific regulatory policy topics. (The focus of this role is engagement with associations and groups that focus on regulatory policy, industry and association regulatory professionals, and other relevant groups rather than direct engagement with regulatory agencies.) Topical areas of focus include, but are not limited to, supply chain resilience, areas of biomedical innovation, new analytical technologies, and advanced manufacturing.
This director will work across the USP organization to engage, leverage, and optimize USP’s scientific and policy expertise as a key component of this enterprise priority. The objectives of this role are 1). to gather stakeholder insights through substantive dialogue to inform USP programs, 2). to contribute USP’s perspective and scientific expertise to policy shaping dialogues, and 3). to leverage collaboration with aligned stakeholders to amplify USP impact on regulatory policy development. The successful candidate will be joining USP’s dynamic Global External Affairs team which engages with a broad stakeholder network including the 500 organizations comprising the USP Convention, public health agencies and practitioner groups, and policy makers on Capitol Hill. We utilize evidence-based perspectives and engage in community dialogue through state- of-the-art communications programming. This leader also will work closely with the USP scientific community to bring the best of USP to some of the most important future-focused dialogues on innovation, supply chain resilience and patient safety.
Roles and Responsibilities
- Lead, develop, and implement USP’s regulatory policy advocacy strategy with identified organizations, working collaboratively across the organization.
- Engage and build relationships with key opinion leaders and subject matter experts, professional groups and associations, and other related stakeholders to gather insights that may shape USP’s work while also contributing to policy shaping dialogues.
- Represent USP externally on key policy topics to appropriately shape and influence the regulatory environment.
- Foster strong partnerships with internal stakeholders to ensure aligned objectives and to identify opportunities for advocacy engagement.
- Support regulatory commenting efforts for assigned priorities, including facilitating the input of USP subject matter experts.
- Coordinate with Government Affairs and Regulatory Intelligence to understand, monitor, and anticipate evolving regulatory and public policy trends and work with internal stakeholders to respond appropriately.
- Bachelor’s degree in a health policy, regulatory, or relevant health-related discipline.
- 10 years of Regulatory Policy or Regulatory Affairs experience with at least three years of professional experience working in the biopharmaceutical industry or a relevant association.
- Recognized as a leader among regulatory policy and/or regulatory affairs professionals.
- Experience working within organizations that host regulatory policy dialogues and/or professional development for regulatory professionals working in life sciences.
- Solid understanding of the U.S. regulatory environment, the Federal Food, Drug and Cosmetic Act, and associated regulations and guidance documents
- Proven success at regulatory, industry, and stakeholder engagement with ability to manage highly complex situations and engender trust when dealing with sensitive issues.
- Experience working in a matrixed environment.
- Strong relationship management and interpersonal skills with outstanding verbal and written communication skills.
- 15 years of Regulatory Policy or Regulatory Affairs experience with at least five years of professional experience working in the biopharmaceutical industry or a relevant association.
- Advanced degree in public policy, public health, law, medicine, or other related field
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities