This position will serve as an ISPE liaison to the major health agencies and is responsible for building and strengthening relationships in support of the Society’s strategic plan. Act as the main point of contact for ISPE’s regulatory arm through strong interactions with agencies such as the FDA, Health Canada, among others.
Principal Duties and Responsibilities
Develop and maintain global regulatory contacts and their respective expertise. With regulatory volunteers and ISPE Consultant/Advisors, build relationships with key decision-makers in ISPE strategic areas of focus.
With Senior Director of Regulatory Operations, ensure effective ISPE regulator outreach such as speaker invitations, document commenting, document review, etc. and align with authority requirements or industry best practices.
Update volunteers and staff and on the impact of new or developing regulations/guidance/practices on ISPE offerings, e.g., apprise the ISPE Guidance Document team of potential impact on in-progress or planned ISPE Guidance Documents.
Identify regulations or emerging industry concerns addressed by current ISPE programs and products. Act as a technical resource for ISPE promotional efforts.
Monitor key health authorities to identify drafts meeting criteria for ISPE comment. Review comments developed by ISPE Comment Lead Teams and advise relevant committees and staff on the position(s) taken.
Work with Senior Director of Regulatory Operations to produce learning opportunities for staff.
Work to disseminate regulatory membership in ISPE and gain their participation on ISPE working groups, initiatives an as speakers and ISPE document reviewers.
Write, source, and/or review regulatory-focused content for ISPE publications.
In collaboration with Senior Director of Regulatory Operations, regularly discuss industry and organizational activities/initiatives for purpose of reporting to the relevant committees, Board and where appropriate, the wider membership.
Education and work experience:
Bachelor’s degree in science, technology, engineering or a related field required. MS/PharmD or PhD is preferred.
12 or more years’ experience of the pharmaceutical industry, preferably in Regulatory, R&D, Manufacturing, Quality or related area with minimum of 5 years in GMP/CMC.
Experience interfacing with government regulatory agencies.
Key regulatory agency experience is desirable. Recent FDA experience preferred.
Demonstrable contributions to a relevant industry or professional association a plus.
Experience of both small molecule (chemical entities) and biotechnology preferred.
Established network of relevant contacts.
Skills and knowledge:
Must be a motivated self-starter with demonstrable leadership skills.
Ability to establish and maintain partnerships.
Must have strong writing, project management and communication skills.
Must possess and demonstrate an excellent understanding of FDA and other global regulatory agencies.
A passion for impacting better healthcare outcomes.
Ability to speak English fluently and write to high standards is required. Fluency in other languages is a plus.
Ability to interact with staff and organization leadership/volunteers (at all levels) in a fast- paced environment is required.
Must be able to work under pressure, remain flexible, positive, proactive, resourceful and efficient, with a high level of professionalism and confidentiality.
Excellent analytical and negotiating skills.
Must possess multi-cultural sensitivity.
Internal Number: 1
ISPE is an individual membership Society for professionals involved in the manufacture of pharmaceuticals and related products.
ISPE was founded in 1980 by a handful of people who believed the pharmaceutical industry needed an organization that would deal with practical applications of science and technology for technical professionals. Their aim was to improve efficiency and best practices. The much-needed forum provided by ISPE began with a Membership of engineers in North America. In time, ISPE Membership expanded beyond engineering to include a broad representation from pharmaceutical professionals, including a vital link with quality control and assurance personnel.
ISPE, which now has 22,000+ Members in 90 countries worldwide, continues to work to keep industry professionals informed of the latest technological and regulatory trends that are occurring in the marketplace. ISPE is committed to the advancement of the educational and technical efficiency of its members through forums for the exchange of ideas and practical experience.