America’s Blood Centers (ABC), North America’s largest network of community-based, independent blood programs, is seeking a Director, Regulatory Affairs and Public Policy. The position is a key role for ABC and will provide the successful candidate an opportunity to lead a strategic area of work while benefitting from the flexibility of a fully remote office environment.
The Director, Regulatory Affair and Public Policy will assist in the development, implementation, execution, and advancement of the ABC Advocacy Agenda before federal agencies and other stakeholders. Robust representation of ABC member interests requires facilitation, member education, evaluation, and coalescing of member input in the development of industry positions, information gathering from internal and external sources, primary and secondary research, and communication skills.
Analyze, evaluate, communicate, and track the impact of new regulatory and science, medical, technical (SMT) developments on ABC member centers, including working with members and staff in the development of policy positions, public statements, and comment letters and responses to information requests from federal agencies.
Assist in the development and execution of the ABC Advocacy Agenda, including environmental scanning for new and emerging public policy issues. Assist in developing strategies to move forward advocacy objectives through regulatory agencies, including member education on the regulatory environment.
Build strategic relationships as a liaison with appropriate staff at FDA and other federal agencies as necessary (including HHS, OSHA, DOL, NCR, CDC, DOD, and others), and non-governmental industry partners.
Serve as an ABC representative and spokesperson to industry coalitions.
Provide regular updates to ABC members and staff on new and emerging regulatory and policy issues, including Member Communication Notices (MCNs), development of webinars, and presentations.
Research and respond to individual member requests for information and assistance in regulatory areas (clarification of guidelines, assistance in interactions with FDA, etc.).
Assist in the development of programs and resources that support member activities in regulatory and policy areas and implementation of new guidance and regulations.
Conduct routine operational and ad hoc member surveys that support the ABC Advocacy Agenda. Work includes the creation of survey forms and protocols, analysis of data, and preparation and dissemination of reports.
Write articles for the ABC Newsletter and other member publications as requested.
Other duties as assigned.
Experience, Knowledge, Skills and Abilities
7+ years of experience with public policy and regulatory affairs, preferably with FDA.
Ability to collect, analyze, and synthesize information from varied sources.
Strong critical thinking, analytical, and problem-solving skills.
Strong communication skills - verbal, written, and presentation.
Strong customer service orientation and ability to navigate and respond to sensitive/ difficult situations.
Self-motivated, flexible, creative, innovative, and goal oriented.
Requires ability to multitask and determine priorities.
America’s Blood Centers employs talented individuals whose passion, drive and skills are necessary to fulfill our mission. America’s Blood Centers offers a salary commensurate with experience as well as an excellent benefit package including medical, dental, LTD, and 401k contribution. We are a virtual office that promotes a flexible work environment. Applicants must be able to maintain a safe, separate workspace in which they can complete their work that is free from distraction and limits accessibly by non-employees and live in an area where they can obtain reliable internet service. This is a full-time staff position including benefits and a stipend for internet and telephone services.
America’s Blood Centers prohibits discrimination and provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.