Job Description

Overview

Senior Manager, Regulatory Affairs - Based in the UK/Homebased

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.

As a Senior manager, Regulatory affairs you will be dedicated to one of our global pharmaceutical clients; a science-based
company with one of the most exciting product pipelines in the industry. This global
pharmaceutical client develops breakthrough innovative medicines to improve and extend
people\xe2\x80\x99s lives in oncology, general medicine and eye care. Working in this way, you will have
the opportunity to build your career in a rewarding customer-focused environment that
supports creativity, collaboration and performance.

Overview

This role will be responsible for all aspects of life-cycle management of assigned Marketing Authorisations (MAs), providing effective regulatory support to the UK and global organisations.

Responsibilities

Responsibilities -

You will have Responsibility for a number of MAs for which the following activities will be required:

• Working closely with global and local colleagues to advise and agree on regulatory strategy and data requirements.
• Critically evaluating submission packages in line with regulatory requirements in order to eliminate deficiencies prior to construction and submission of MA applications within agreed timeframes.
• Monitoring and influencing assessment process to expedite and optimise the outcome of their submissions.
• Driving negotiations with MHRA to ensure best possible outcome which may include for example, optimal product labelling or assurance of supply continuity and delivery of their commitments and deadlines.
• Ensuring communication of any regulatory changes to the business as necessary to support licence compliance.
• Submission and maintenance of official local drug information, including Patient Information Leaflets, SmPCs, packaging texts, RMPs and their Educational Material.
• Independently manages new MA submissions eg Scientific Advice meetings, attendance at launch meetings, pre-vetting materials and stock readiness.
• Managing CTA submissions and ongoing lifecycle management of local UK trial as required.

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
• UK (MHRA) ethical pharma experience 3-5 years.

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That\xe2\x80\x99s why we are committed to developing our employees in a continuous learning culture \xe2\x80\x93 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.

ICON