Clinical Regulatory Coordinator

Zoek Pin London, Greater London, England

Competitive

Permanent (Full time)

Recently Posted

POSITION LOCATION: Canada/US/Netherlands/Germany/UK

POSITION TITLE: Regulatory Coordinator (Full-time, Limited-term)

POSITION REPORTS TO: Manager, Regulatory Affairs

DEPARTMENT/UNIT NAME: Regulatory Affairs

JOB SUMMARY:

Support the development, completion and maintenance of clinical trial applications to Competent Authorities and Ethics Committees for projects on behalf of Corporate Clients, Sponsors, Academic partners and/or other applicants. Assist the unit to complete and report on findings from regular reviews of industry best practices, regulatory requirements and standards; maintain application submission calendar; contribute to development of application tools and templates; and coordinate regulatory submission activities that ensure all project regulatory submissions are submitted on a timely basis, are accurate, include all required and relevant information, and meet or exceed all local, regional, national and/or global application submission requirements.

AREAS OF RESPONSIBILITY:

Regulatory Submission Tracking

o Monitor, maintain and/or amend local, regional, national and global regulatory/ethics/academic submission calendar ensuring it remains current.

o Provide project teams with estimated/actual submission and approval timelines, and amendment submissions and post approval commitment deadlines by jurisdiction, throughout the project life cycle.

o Provide regular updates to project teams and sponsors on status of submissions against project deliverables and timelines.

Project Support

o Coordinate the regulatory submission calendar including important dates and milestones.

o Develop, maintain and review Informed Consent Forms at the project, region and site level.

o Contribute to the preparation and completion of initiation/activation readiness forms.

o Provide regulatory verification and/or investigator regulatory approval services and drug label review services to sponsors.

o Assist document specialists with the dissemination of updated site documents and in conjunction with the Document Management Team, the completion of document quality reviews when appropriate.

Regulatory Guidelines and Standards Support

o Continually review, interpret, update and disseminate local, regional, national and global regulatory requirements, guideline and policies to project teams and stakeholders, staying abreast of current and upcoming changes in the regulatory climate that may affect internal regulatory processes for clinical projects.

o When required, participate in industry activities, interact with and advocate on behalf of sponsors with external partners and agencies.

Regulatory Submissions

o Responsible for the completion of Competent Authority and Ethics Committee submissions, facilitating the preparation of submissions and collection of supporting documents and reports, preparation of standard reports, communications and/or responses to questions and monitor completion of post approval commitments.

QUALIFICATIONS:

Applicants should have a minimum of an undergraduate degree or college diploma, in addition to 1-3 years of relevant experience (ideally Clinical Research, Life Sciences, or Professional Services). Post-graduate education in Regulatory Affairs (with a focus on EMA) or related certifications are considered an asset. Strong English & Dutch communication skills are required,

WORKING CONDITIONS:

Office/Home based

*Accommodations for job applicants with disabilities are available upon request.

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