Regulatory Submission Manager

RHL

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Job ID :

12335


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

United Kingdom,Kent,Kent,


Key Skills :

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


Salary :

Negotiable


Date Posted :

27 Jul, 2018



Company Name :

RHL


Location1 :

Kent




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Temporary


Travel Amount:

negotiable





Description

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; Danni@rhl.co.uk, 01233 658037



RHL is a specialist Recruitment Consultancy within Life Science talent acquisition.



Recruitment Holdings Ltd (RHL) acts as an Employment Business and as an Employment Agency.


Company Name:

RHL


Headquarters:

The Cedars,Church Road


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

TN231RQ


Website:

www.rhl.co.uk


Employees:

less than 100


Industry:

Pharmaceutical Recruitment


City:

Ashford


Phone No. :

01233 658018


For more information,visit www.rhl.co.uk.

View all RHL Jobs



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