Manager / Senior Manager, Regulatory Strategy

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Job description

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.

With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

*Position overview:*

As a Manager / Senior Manager of Regulatory Strategy you will be responsible for the successful execution of regulatory affairs activities within the Regulatory Strategy and Agency Liaison group within ICON. You will have the opportunity to work on a variety of different projects in this client-facing role and perform different development, MAA and lifecycle management activities.

your responsibilities will include:

* To successfully execute on the regulatory strategy for your assigned projects, managing the agency liaison activities for various products and submissions.

* To compile agency submissions for regulatory pathways including but not limited to scientific advice, pediatric investigation plans, orphan drug designations, marketing authorizations, product variations and renewals of international medicinal products.

* To provide expert regulatory advice to a range of clients.

* To successfully interface and negotiate with international Health Authorities.

* To collaborate with other subject matter experts internally at PRA, including Medical Writing, Regulatory Operations, Labelling and CMC.

* To manage and guide our clients in their development and post market activities.

* To apply your regulatory strategy knowledge to enhance probability of regulatory success or enhancing regulatory compliance.

Working in this close-knit team is varied and will evolve as the department grows. As such, you can expect to see your knowledge and career expand in line with this evolution.

*Requirements:*

* A minimum of an undergraduate degree in a life-sciences discipline (or be a licensed healthcare professional).

* A proven track record of success in managing projects and executing on regulatory strategies.

* Extensive experience with EU and ideally international markets

* Hands-on experience with the submission marketing authorization applications, scientific advice procedures and lifecycle maintenance (renewals, extensions etc)

* A collaborative and team-focused approach to work.

*Benefits of working in ICON*

Our success depends on the knowledge, capabilities and quality of our people. That's why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

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, 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.