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Regulatory Affairs Manager

Role Responsibility

As 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
Minimum five years Pharmaceutical/CRO experience including minimum 5-7 years Regulatory Affairs experience or equivalent
EU/APAC: 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
Good written and spoken English.
Proficient in the use of Microsoft Office.
Bachelor’s degree, or local equivalent, preferably in the sciences, or equivalent experience qualification. Masters degree or higher preferred.

Benefits of Working in ICON

Other than working with a great team of smart and energetic people, we also offer a very competitive benefits package. This varies from country to country so a dedicated recruiter will discuss this with you at interview stage.

We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.

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.

Or you can contact directly Olivier Hembise, TA at ICON Japan : olivier.hembise@iconplc.com

A better career. A better world. A better you.

Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader.
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Regulatory Affairs Manager

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