This position provides support for the daily operations of ISPE’s Regulatory department as well as general office operations. The Regulatory Operations Coordinator will provide administrative support for programs and initiatives carried out by ISPE volunteer groups, and will be responsible for tracking, summarizing and disseminating information on these groups to various sources. Responsibilities also include preparing and assembling ISPE commentary on regulatory documents and communications related to regulatory speakers.
Primary function: Regulatory Department support
Principal Duties and Responsibilities
Compose correspondence for global regulators (e.g., speaker invitations, event itineraries).
Submit speaking invitations to global agencies and track status.
Provide administrative support to multiple association committees, subcommittees and task forces, liaising with committee chairs in the development of meeting/conference call scheduling, agendas and minutes.
Track committee activities using various formats (summaries, spreadsheets, presentations).
Maintain committee member records in association management system (iMIS).
Schedule and coordinate all steps the commenting process to meet regularly agency deadlines.
Research documents released for public comment on regulatory agency websites when necessary.
Write summaries of committee activity to publish in ISPE vehicles
Draft short communications for Society’ publications
With ISPE’s Marketing/Communications team, maintain and enhance the regulatory pages on the ISPE website.
Other duties as assigned.
Education and work experience:
Bachelor’s degree along with one to three years’ professional experience in an administrative support position.
Experience in an association or non-profit environment preferred.
Skills and Knowledge:
Intermediate skill in Microsoft Office products.
Ability to work independently with minimum supervision and manage multiple concurrent projects with attention to detail.
Must have excellent writing skills with the ability to synthesize and summarize material for written reports and presentations.
Candidates must have the composure and confidence to interact with ISPE’s senior leaders and the exhibit diplomacy, tact and professionalism while still advancing tasks.
Must be able to discern sensitive issues and handle them in complete confidence.
Able to plan, organize and carry out work from a variety of sources to meet deadlines and achieve objectives.
ISPE, the International Society for Pharmaceutical Engineering is the world’s largest not-for-profit association serving its Members through leading scientific, technical, and regulatory advancement throughout the entire pharmaceutical lifecycle. ISPE is the Society of choice for nearly 22,000 pharmaceutical manufacturing professionals in 90 countries. Founded in 1980, ISPE has worldwide headquart...ers in Tampa, Florida, a European office in Brussels, and Asian-Pacific offices in Singapore and Shanghai. Visit www.ispe.org for additional Society news and information. ISPE offers excellent benefits including medical, dental, vacation, paid holidays, 401(k), and more.