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Manager, Regulatory Strategy
3 months ago
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.
Manager, Regulatory Strategy:
United Kingdom- Remote or Hybrid (Reading, Swansea), Ireland
The Role:
We are looking for passionate, resilient, and inspiring individuals to join our team. As the Manager, Regulatory Strategy, you will represent the Regulatory Affairs function on project teams and client meetings to provide regulatory guidance and strategy specifically focused on leading US FDA meetings and submissions support drug market transitions.
Job Description Summary:
Participate in provision of Regulatory expertise in strategic drug development across multiple areas.
Take part in preparation of strategic development and submission plans.
Be involved in the regulatory affairs activities across the ICON portfolio and be an expert and advisor to ICON clients (externally and Internally)
Be a trusted partner - represent the Regulatory Affairs Department in business development activities and generate new business opportunities
Contribute to at least two of the following areas: Interactions with Regulatory agencies, early phase consulting, Development Planning (PDP/RDP/CDP), Scientific/Agency advise, orphan drugs/pediatric development, medical devices, Reg Intelligence, due diligence, strategic CT support/GCP compliance, biologlcal/blotech/biosimilars, small company support (incl. SOPs development etc.)
As Regulatory Expert, build effective teams and Involve junior members of the team into more complex regulatory issues. Mentor and train across function to support the wider Regulatory Department.
Knowledge/Skills/Attributes
Leading FDA pre -IND, End of Phase 2 and Pre NDA/BLA meetings with FDA.
Experience with small molecules, biologics, gene therapy and cell therapies.
Post market support experience
Excellent verbal and written communication: Conveys thoughts in a clear, concise, and accurate manner. Uses appropriate regulatory, medical, and scientific nomenclature. Listens carefully and asks questions when necessary to ensure understanding
Planning and organization: Plans work effectively to meet goals and ensure timely completion of assignments. Manages time effectively.
Attention to detail: Identifies and resolves discrepancies across various source documents, including published and unpublished documents. Notes and resolves errors in written documentation
Experience in client interaction and/or in a consulting environment is advantageous
Experience in regulatory writing, meeting packages, dossiers
What you need
Minimum of a Bachelor’s degree in Regulatory/Life Sciences
Strong background and Regulatory experience in Pharma, Biotech, or related industry with emphasis on US Regulatory Affairs
Knowledge of IND/NDA/BLA requirements
Experience liaising with the FDA and conducting meetings to resolve any issues/concerns
Comfortable being in an advisory based position to present, meet client requirements and a precise, professional and personable approach.
Experience supporting client development activities and people management.
Experience in Gene Therapy preferred
Sound knowledge of the life cycle of a drug development program
#LI-HP2
#LI-Remote
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, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers.
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.
Are you a current ICON Employee? Please click here to apply
