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Regulatory submissions manager

Xico, Ver
Icon Plc
Publicada el 14 marzo
Descripción

Remote - position
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
- lead regulatory activities and submissions independently, with prior experience in areas such as cta/ind/maa
- provide regulatory guidance and efforts to internal teams
- participate in agency interactions and regulatory submissions
- contribute to developing best practices within icon regulatory affairs through your insight of regulatory processes and guidelines
- work collaboratively as part of a regulatory or cross-functional team, depending on project size and nature
your profile
- bachelor's degree in a scientific or healthcare-related field; advanced degree preferred
- minimum of 6 years of experience in regulatory affairs within the pharmaceutical or biotechnlogy industry
- prior experience with various regulatory submissions, including cta/ind/maa
- ability to lead internal teams and carry out regulatory activities independently
- strong understanding of global regulatory requirements and guidelines
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 maximize 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 site
to read more about the benefits icon offers.

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