Regulatory Submission Manager


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Job ID :


Company Type :

Staffing Firms

Industry :


Education Level :


Address 1 :

United Kingdom,Kent,Kent,

Key Skills :

Regulatory, Clinical, CTA. Submission, Trial, Translations,

Salary :


Date Posted :

27 Jul, 2018

Company Name :


Location1 :


Job Category :

Regulatory Affairs Jobs

Experience :


Job Type:


Travel Amount:



Are you looking for your next contract opportunity? Something that will take you to the next step in your career, whilst working for a global biopharmaceutical company?

We are looking for a Regulatory Submission Manager to join our client's team in Kent. You will be a responsible for working with contributing business lines to lead operational submissions execution for designated CTAs.

Job Title: Regulatory Submission Manager

Reference No: 241522

Location: Kent
Job Type: 12 month Contract
Salary: To be discussed

Job Description:


Operate as regulatory operational Subject Matter Expert for a CTA and drive submission teams towards the timely delivery of globally compliant submission-ready components.

Provide an interface to Regulatory and GPD partners within designated Business Units, offering project leadership and expertise in the logistics involved with execution of regulatory CTA submissions to regional partners and selected Health Authorities.

Drive global submission management activities for their assigned assets.

Liaises with Study Management, regarding essential core documents that cross both HA and EC submission and translation processes

Prepare, review and submit submissions to HA/Regional CTA Hub, in order to obtain all necessary authorisations/approvals pertaining to the clinical trial conduct.

Responsible for the co-ordination of translations for core documents required for submission.

Support and leads global team efforts to ensure high quality components and submissions that are compliant with industry, agency and format guidelines, regulatory strategies, policies, and timelines.

Promotes the use of Document Management and Archival systems and standard document authoring, partnering with supplier groups as necessary in order to produce timely delivery of submission/archive ready components.

Person Specification:


Strong knowledge of the drug development process, regulatory affairs, Clinical Trial Applications and submissions management.

Proven aptitude in leadership, problem solving and logistics

In-depth understanding of systems and electronic technologies used to support submission and planning activities, as well as demonstrated experiences in process development and new technology implementation.

Demonstrated understanding of regional and national regulator filing guidelines and dossier requirements.

Degree in a Life Science discipline

In-depth understanding and proven execution of CTA processes globally

Comprehensive understanding of ICH/GCP & EU Clinical Trial Directive

Please apply to Danni Arnold, Consultant;, 01233 658037

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