Regulatory Submissions/Documentation Consultant

Location
Oxfordshire
Salary
£45 to £50 per hour
Posted
18 Jun 2018
Closes
16 Jul 2018
Ref
J56234
Contact
Haseena Mooncey
Contract Type
Contract
Hours
Full Time
We are currently looking for a Regulatory Submissions/Documentation Consultant to join a leading company based in the Oxfordshire area. As the Regulatory Submissions/Documentation consultant you will be responsible for the preparation and maintenance of regulatory submission documentation, which includes the preparing, formatting and publishing and archiving of paper and electronic submissions, working to quality standards and strict deadlines.

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the Regulatory Submissions/Documentation Consultant will be varied however the key duties and responsibilities are as follows:

1. As the Regulatory Submissions / Documentation Consultant you will help develop and maintain a GxP/ISO compliant regulatory function, including helping and supporting GxP inspection.

2. In your role as the Regulatory Submissions / Documentation Consultant, you will assist in the writing of regulatory submissions to regulatory agencies, and organise and maintain submission components associated with a regulatory submission. You will set up and maintain regulatory documentation templates and filing structures, and also author and format simple documents, as well as QC duties.

3. You will also compile and publish regulatory submissions for assigned products/projects, following guidelines. You will be managing the printing and submission of documentation to the relevant agencies within given deadlines, and also coordinate submission and product lifecycle information.

4. Other duties as the Regulatory Submissions / Documentation Consultant will include assisting with the writing, reviewing, coordinating internal work instructions, standard operating procedures (SOPs), change controls, deviations and corrective and preventative actions (CAPAs).

ROLE REQUIREMENTS:

To be successful in your application to this exciting opportunity as the Regulatory Submissions/Documentation consultant we are looking to identify the following on your profile and past history:

1. Relevant BSc degree in a relevant scientific discipline.

2. Proven industry experience of at least two years working with document and submissions management in a pharmaceutical/biotech setting.

3. A working knowledge and practical experience with electronic document management software, eCTD publishing software and Registration Tracking (e.g. FirstDoc, eCTD Xpress, Veeva, Docubridge), electronic submission systems/portals (e.g. IRAS, CESP, Eudralink, FDA ESG), principles of information systems, and related technology, is required.

Key Words: Regulatory Affairs / Documentation / Publication / CTD / eCTD / Trial Master File / TMF / Design History File / DHF

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