Regulatory Affairs Manager

Regulatory Affairs Manager - Homebased in the UK/Europe

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

The Regulatory Affairs Manager is responsible for day-to-day coordination and preparation

of regulatory submissions.  The Manager will work and interact with internal crossfunctional

team members in order to create regulatory submission documents that are compliant

with EU and/or global regulatory requirements and he/she will act as official liaison

with European Regulatory Agencies for the assigned projects.

He/she supports planning and executing regulatory document preparation for regulatory

submissions in Europe and in International geographies for CTAs. He/she keeps abreast of

evolving regulatory procedures and practices.

The manager will:

• Represent Regulatory function in assigned Study Teams
• Manage and prepare CTAs WW until approval of particular studies
• Manage the creation, review, and submission of CTA regulatory documents to support
• product development and clinical trials applications in Europe (EU, UK, Switzerland) as
• well as rest-of-the-world countries (US excluded). 
• Collect reports and documentation and coordinate the content and format of CTA
• submissions according to health authority requirements.
• Create regulatory submissions from internal reports.
• Maintain current knowledge of relevant European and international guidance’s, laws and
• regulations, and proposed and final rules which affect pharmaceutical drug development
• and companion diagnostics.
• Ensure regulatory guidance documents and laws, as well as internal policies and
• procedures, are followed to ensure regulatory compliance is maintained.
• Review regulatory agency submission materials to ensure timeliness, accuracy,
• completeness, and compliance with regulatory standards.
• Ensure that dossiers containing quality, preclinical, and clinical data are presented
• clearly and succinctly to optimize the regulatory review and approval process.
• Ability to read and understand all components of a regulatory submission (CTA/MAA)
• to ensure consistency across documents.

• BS degree, preferably in a scientific discipline with a minimum of 3 years regulatory
experience and/or drug development experience.
• Experience in interactions with regulatory agencies. Experience with clinical trial
applications
• Project management and interpersonal skills is a requirement, as well as excellent
written and verbal communication ability
• Experience in EU-CTR and CTIS process
• Experience in the UK CWoW
• Excellent communication skills; both oral and written.
• Demonstrated ability to contribute to a continuous learning and process improvement
environment.
• Excellent analytical and organizational skills and ability to support multiple projects in
a timeline-driven environment.
• Experience with document management systems, eCTD submissions managing, and
maintaining regulatory files preferred.