Senior Operations Lead, Regulatory, RS

Senior Clinical Regulatory Specialist (Operations Lead, Regulatory)

Location:  Spain

ICON are currently looking for a Senior Clinical Regulatory Specialist to join our Real World Evidence team in the Barcelona or Madrid office preferably. Working within our Real World Evidence team, you will work with a team of professionals who provide strategic and operational expertise in the design and conduct of Post-Approval and commercialization programs for Pharmaceuticals, Biologics and Medical Devices. 

Combining the industry’s oldest and most experienced Clinical Outcome Assessments (COA) consultancies (Mapi & Oxford Outcomes), within ICON Commercialisation and Outcomes, and with access to more combined COA experience than all other CROs and consultancies, we can offer fantastic career opportunities. We provide a dynamic, stimulating and rewarding working environment for ambitious and passionate individuals looking to join a global, world-class consultancy business.

Your Responsibilities and Accountabilities:

The Regulatory Specialist works closely with the site contracts and ethics and regulatory teams in providing support in managing all regulatory aspects of the assigned projects in accordance with protocol specifications, applicable guidelines, regulatory requirements and SOPS. 

Responsibilities:

In the role of Regulatory Specialist, you will be:

• Responsible for oversight of regulatory and ethics submissions for assigned projects/countries (all regions)/sites, which may include completion of submissions or notifications, as required.
• Responsible for oversight of studies start-up phase until SIV completion, ensuring that all start-up activities are performed within the defined timelines.
• Responsible for providing advice and support to the project team for regulatory aspects of the clinical trials and late phase studies. 
• Responsible for providing regulatory support as needed for drafting applicable study documents, including the protocol and informed consent form. 
• Responsible for investigating proactively and capitalizing regulatory information collected throughout studies and maintain Regulatory database accordingly. 
• Responsible for providing input and oversight for ongoing development and enhancement of systems used in the frame of Clinical Regulatory Affairs activities. 
• Responsible for updating and maintaining regulatory information in the Study Management System and/or reporting mechanism, and for ensuring appropriate paper and electronic filing. 
• Responsible for liaising with other departments on requirements for regulatory and ethics submissions. 
• Participating in the improvement of the Quality Assurance System.

You will have: 

• Education to degree level
• Strong knowledge of ICH/GCP guidelines or other relevant guidelines (GEP, GPP or local requirements)
• Proficiency with computer systems
• Strong verbal and written communication skills
• Strong organizational, time management, interpersonal skills.
• Ability to work both independently and in a team environment.
• Fluent in English 

Next Steps:

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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