Regulatory Affairs Specialist

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

What you will be doing:

• Monitor and search National Medical Products Administration (NMPA) relevant laws, guidelines and other pieces of regulatory information (draft/in force) from Health Authority (HA) webpages and public databases, public conferences, workshops and associations activities;

• Prepare and issue weekly and monthly China regulatory and intelligence report (and alerts when necessary);

• Coordinate to collect and consolidate Novartis internal comments on draft legislation/guidance and submit the company position and comments to the HAs or associations before due dates, such as the R&D Based Pharmaceutical Association Committee (RDPAC) and the Pharmaceutical Research and Manufacturers of America (PhRMA);

• Monitor Center for Drug Evaluation (CDE) backlog solving progress and key projects moving speed in CDE to support Regulatory Affairs (RA) planning and strategy adjustment;

• Utilize external information from CDE website or provided by vendors about regulatory information (such as GBI, Insight), to support RA team to set up internal data base for well planning and communications.

• Coordinate other regulatory intelligence work assigned by Global Drug Development (GDD) China RA office and Head of China Policy.

• Coordinate internal regulation/guideline trainings to RA colleagues about emerging regulatory requirements by or cross functionally and via written communication, such as newsletters, information e-mails, etc.

You are:

• Education: BS degree or above on pharmaceutical, medical or Bio science Language: Fluency in English as a business language, good written English will be a plus
• Experience:
  • Handled registration project and familiar with NMPA drug registration regulation and process
  • Monitoring and search of relevant laws, guidelines and other pieces of regulatory information from Health Authority web-pages and public databases, public conferences,
  • Having people net with RA of industry
• Personality: good at communication, open mind and team work spirit

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.