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Job Details

Regulatory Affairs Submission Specialist

Company: Regulatory Professionals
Location: West London
Reference: J30871
Closing Date: 14 Dec 17
Type: Full Time
Salary (£): Negotiable
Benefits: Competitive + Benefits

Job Summary:

Regulatory Professionals are supporting the recruitment of a Regulatory Affairs Specialist who will have the opportunity to join a global Biopharmaceutical company, specialising in providing life changing treatments for those with unmet, urgent medical needs.

Requirements:

Regulatory Affairs Submission Specialist
Competitive Salary
Location: Uxbridge
Reference: J30871

Regulatory Professionals are supporting the recruitment of a Regulatory Affairs Specialist who will have the opportunity to join a global Biopharmaceutical company, specialising in providing life changing treatments for those with unmet, urgent medical needs. They are looking for a talented and motivated individual to join their team, specialising in submissions.

The responsibilities are outlined below:
*Support of the Regulatory Affairs staff in the coordination, preparation and submission of all INDs, NDAs, MAAs and lifecycle management of these submissions using EDMS and electronic publishing.
*Maintenance of all regulatory and FDA correspondences and archiving into EDMS.
*Creating, assembling and publishing both major and routine global paper and electronic submissions.
*Planning, gathering, tracking, dispatching and archiving regulatory documents and submissions in paper, eCTD and other electronic format.
*Working with regulatory document authors to achieve resolution and ensure documents comply with regulatory, company guidance and template specification.

The following qualifications and experience are necessary:
*Achieved a Bachelor's Degree or equivalent.
*Industry experience including Regulatory Operations.
*Experience publishing eCTD using electronic publishing systems.
*Knowledge of electronic submission trends.
*Experience with MS Office Suite and Adobe Acrobat application.

Our client also offers a brilliant salary, along with a strong benefits package.

Regulatory Operations, IND, NDA, MAA, eCTD, Pharmaceutical, lifecycle management, electronic publishing, Uxbridge, West London, Hillingdon, Stratford, Ealing, Harrow, Hounslow, submissions, regulatory affairs.

Apply for this job: Regulatory Affairs Submission Specialist

Contact Information:

Address:  UK Office
3rd floor 33 Blagrave Street Reading
RG1 1LG
England
Tel:  +44 (0)118 9522 797
Website:  Visit Our Web Site

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