EU regulatory lead - Homebased in Ireland, France or Spain - 1 year fixed term contract

EU regulatory lead - Homebased in Ireland, France or Spain - 1 year fixed term contract

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.

Senior Manager, Regulatory Strategy (EU Regulatory Lead) - Homebased in Ireland, France or Spain - 1 year fixed term contract

We are currently seeking a Senior Manager, Regulatory Strategy (EU Regulatory Lead) to join our diverse and dynamic team. As a Senior Manager, Regulatory Strategy at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.

The EU Regulatory Lead is responsible for developing and implementing regulatory strategy leading to successful registration and life-cycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs in the region in scope (EU Lead + strategic support to the local regulatory teams)

The successful candidate will undertake leadership of cross- functional teams in major regulatory submissions (MAA, CTA, ODD, PIP), Health Authority Interactions, label discussions, and securing MAA approvals. As a regional regulatory lead or contributor, the EU Lead is accountable for providing the region-specific Regulatory strategy and advice.

What you will be doing

• Accountable for delivering on various regional regulatory strategic areas such as orphan designation, scientific advice, paediatrics and submission content and objectives. This includes health authority engagement strategy and considerations of expedited regulatory programs.
• Lead cross-functional Teams in major health authority interactions. This includes setting the strategy and planning for the interaction, driving the formulation of the briefing document focused on strategy and scientific content, leading the team through meetings rehearsals, and moderating the meeting itself.
• Lead or manage projects or complex products through all stages of the regulatory process, while providing expert advice in specific regulatory areas
• Provides advice on regulatory issues for both marketed and pipeline products; actively collaborates with management and cross functional colleagues
• Coordinates submissions to regulatory authorities in support of proposed and ongoing development programs, e.g., new clinical trial application submissions, amendments, etc. 
• Monitor the development of new regulatory requirements or guidance documents and advise product teams of the impact on the business or development programs Provides support to regulatory affairs reviewers for due diligence initiatives, including opportunity and risk assessment.

• Leading interactions with regulatory agencies and preparing submissions.

Your profile

• Extensive experience in managing and driving regulatory strategy for drug development within Europe
• Previous experience in managing the strategy for lifecyle management activities
• Confidence in attending scientific advice meetings and interacting with Health Authorities globally
• A background in oncology would be beneficial, but is not absolutely required
• Fluency in English
• A relevant degree-level education, in a relevant life-sciences discipline

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.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, 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