Senior RA Manager

Location: Europe wide (home working available)

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

With our patients at the center 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.

The role:

As Senior Regulatory Manager, you will work in Global Regulatory Affairs and form part of the EU and Asia-Pacific Regulatory team, a successful and driven team that provides consultancy for all ICON projects globally as well as standalone contracts with clients. You will support the... Regulatory Project Lead and dependent on the size of and nature of the project assigned, you may act as the Regulatory Project Lead and deal directly with the sponsor and Regulatory Agencies.

Additional Responsibilities:
• Effectively manage Regulatory Affairs activities on regulatory projects and/or clinical trials being undertaken by ICON.
• Duties will be variable depending on the nature of the projects to be undertaken. These will mainly fall within the areas of Pharmaceutical, Biotechnology or Biologics Regulatory Affairs but may be concerned with: Agrochemicals, Cosmetics, Foods, Medical Devices and Veterinary products. Works on a range of regulatory issues in which analysis of situations or data requires an in-depth evaluation of diverse factors.
• May work either alone or as part of a regulatory or cross-functional team depending on the size and nature of increasingly complex projects.
• Act as Regulatory Project Lead but may also report to another Regulatory Project Lead as required.
• If acting as Regulatory Project Lead, responsible for managing each project and for monitoring and reporting progress and is accountable for all matters relating to that project and for communication with the client.
• Represent the Regulatory Affairs Department in business development activities.
• To be familiar with and to work in accordance with relevant ICON SOP’s and internal systems, GXP and appropriate regulations and guidelines.
• Recognize, exemplify and adhere to ICON's values which centre on our commitment to People, Clients and Performance.
• As a manager, the employee is expected to recognize the importance of and create a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
• To be familiar with and to work in accordance with relevant ICON SOP’s and internal systems, GXP and appropriate regulations and guidelines.
• Apply scientific principles and maximize compliance to all aspects of regulatory activities undertaken.

Additional Functions/Responsibilities as Regulatory Project Lead
• Primary point of contact between ICON and the Client
• Management of the designated project in accordance with the agreed project planning and control documentation, including initiation and maintenance of the project plan
• Management of the assigned regulatory project team
• Production of project status reports at agreed intervals
• Ensuring that checking and auditing procedures are carried out
• Control of all project related documentation either in paper or electronic form
• Monitoring and advising on compliance with agreed budget relating to the project

Experience and Qualification:
• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
• EU In depth proven experience in regulatory affairs or aligned work.
• Demonstrable experience within regulatory affairs, including document preparation and/or writing, clinical trials, post-licensing activities and regulatory agency interaction
• Strong organizational skills, ability to manage multiple tasks and meticulous attention to detail.
• Excellent written and communication skills
• Effective project management skills
• Good written and spoken English.
• Proficient in the use of Microsoft Office.
• Ability to multi-task and support various projects
• Ability to maintain a high level of accuracy and attention to detail
• Bachelor’s degree, or local equivalent, preferably in the sciences, or equivalent experience

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 through the form below.

What’s Next?

Following your application, you will be contacted by one of our dedicated recruiters and if successful we will be able to provide you with more details about this opportunity.

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Dublin Ireland

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