Regulatory Submissions Coordinator
- Experience Level
- Experienced (non-manager)
Role: Regulatory Submissions Coordinator
Location: Central London
Salary: Competitive + benefits
employment: full time, permanent
Regulatory Professionals are collaborating with a midsize, clinical contract research organization. They provide services for Phase I-IV of drug and medical device development services including regulatory services and central laboratory services. Our client is seeking a regulatory affairs professional who will be responsible for distributing, tracking, reviewing, and approving individual site Trial Master File (TMF) essential documentation at project start and collect, review, organise and assemble regulatory startup submissions.
There are different levels to this role as seen below therefore if you have 1-5 years worth of experience managing the following, please apply!
Other duties will include:
Distribute, track, review, and approve individual site Trial Master File (TMF) essential
Provide advice and guidance to internal and external team members to ensure compliance with applicable regulations and requirements;
Review pertinent regulations and guidance to develop proactive solutions to regulatory submissions issues and challenges;
Utilize and assist in maintaining ClinTrak (e.g., Essential Documents module);
Work with Document Centre to ensure necessary documentation is present; and
Train and assist Clinical Research Associates on a collection of essential documentation for the on-going phase of the project. Review documentation submitted by Clinical Research Associates and forward to client/Document Centre.
Regulatory Submissions Coordinator - Entry
Duties are performed with close supervision and guidance from supervisor. The employee should begin to develop a basic understanding of clinical research and study start-up.
Proficient knowledge of Microsoft Office software and Adobe Acrobat;
Demonstrate time management and professional oral and written communication skills; and
Demonstrated ability to think critically, independently, and exercise good judgement.
Regulatory Submissions Coordinator I
The employee is experienced enough to coordinate start-up and regulatory maintenance activities day-to-day with minimal orientation and oversight. A rapid increase in knowledge and understanding of study start-up and maintenance activities is expected.
Bachelors degree and at least 1 year of pharmaceutical or clinical research experience, or masters degree within Life Sciences;
Broad knowledge of clinical trial conduct, specifically, study start-up;
Demonstrate fundamental knowledge of the International Conference on Harmonization (ICH) guidelines and FDA or applicable local regulations; and
Ability to interact effectively with our client's team members and investigative sites.
Regulatory Submissions Coordinator II
The employee is experienced enough to function independently on a day-to-day basis with minimal orientation or oversight related to core responsibilities. Some oversight may be necessary for certain assignments.
Bachelors degree with at least 1 year of Regulatory Submissions experience at Coordinator level or equivalent (excluding time spent in an entry-level position in the industry) or Master's degree within Life Sciences and at least 1 year of Regulatory Submissions experience at Coordinator level or equivalent;
Independent development and tracking of study start-up documents (status reporting, timelines, etc.);
Demonstrate comprehensive knowledge of FDA or applicable local regulations, ICH guidelines, and Sponsor Standard Operating Procedures; and
Ability to interact with all our client's team members and Sponsors on project-related issues.
Regulatory Submissions Coordinator III
The highly proficient individual in Regulatory Submissions. The employee has enough experience that minimal project training is required. Expected to perform Regulatory Submissions Lead duties for moderately sized projects as assigned. In addition, the employee will provide insightful input on regulatory submissions documents (i.e., process, templates, TMF contents, etc.) and study start-up strategy.
Bachelors degree and at least 3 years of regulatory submissions experience, or masters degree within Life Sciences and at least 2 years of regulatory submissions experience;
Demonstrated ability to lead projects, performing all necessary duties in an accurate and timely manner; and
Demonstrated ability to contribute to process/document improvements.
Senior Regulatory Submissions Coordinator
A senior-level positions. Highly proficient in all Regulatory Submissions activities. As necessary, this employee has the ability to successfully act as the Study Start-up Lead on assigned studies and is also able to efficiently manage departmental projects. Expected to communicate independently with external clients, vendors, and sites while keeping line and study management informed regarding project-related activities. In addition, the employee is capable of performing Regulatory Submission Lead duties for large global projects as assigned.
Bachelors degree and at least 5 years regulatory submissions experience, or masters degree and at least 4 years of regulatory submissions experience;
Advanced knowledge of Institutional Review Board (IRB)/Ethics Committee (EC) processes, regulatory submissions, FDA or applicable local regulations, ICH guidelines, and our clients study start-up processes;
Demonstrated ability to provide leadership and guidance to other Regulatory Submissions Coordinators; and
Demonstrated ability to support and augment department initiatives.
If you would like to apply for this position, please contact Amani via amani.yousef@CPL.com. If you are not currently looking but know someone who would be good for this role then get in touch. We offer a referral scheme at Regulatory Professionals where in which a successful recommendation will earn you 250 worth of vouchers *terms and conditions apply*
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