Regulatory Strategist 2

ICON Strategic Solutions Denver, CO, CO
regulatory strategist regulatory icon strategy regulatory strategy medical people strategist healthcare clinical research research health
November 22, 2022
ICON Strategic Solutions
Denver, CO, CO
FULL_TIME
Overview
Regulatory Affairs Strategist - Homebased - East Coast USA
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.
Due to recent success within one our Innovative Biotech Clients I am recruiting for a Regulatory Affairs Strategist at ICON - Working in a client-dedicated yet fully embedded role ICON's Regulatory Strategy group, you will lead or contribute to the development and execution of the drug development strategy of our client's new therapeutics.
Responsibilities
You will play a key role in:
- Successfully executing on the regulatory strategy for your assigned projects, managing the agency liaison activities for various products and submissions.
- Compiling 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.
- Successfully interface and negotiate with international Health Authorities.
- Collaborate with other subject matter experts internally at ICON, including Medical Writing, Regulatory Operations, Labelling and CMC.
- Managing and guide our clients in their development and post market activities.
- Applying your regulatory strategy knowledge to enhance probability of regulatory success or enhancing regulatory compliance.
Qualifications
You are:
Adaptable, collaborative and an expert in regulatory strategy.
Here at Icon we want our employees to succeed and ensure that they are set up for this success through constant training, development and support. To enable success in this position you will have:
· 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.
· Hands-on experience with the submission of MAAs (ideally via centralised procedure) and scientific advice procedures.
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.
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Posted Date 2 weeks ago (11/4/2022 1:40 PM)
ID 2022-96749
Location : Location US-Remote

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