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Job Details

Regulatory Submissions Specialist

Company: SRG Clinical
Location: Berkshire
Reference: J23094
Closing Date: 01 Sep 17
Type: Part Time
Salary (£): Negotiable
Benefits:

Job Summary:

SRG are currently looking for Regulatory Submissions Specialist for a Global Pharmaceutical Company who have opened a new vacancy within their Regulatory team on an initial 12 Month basis to be based at their offices in Berkshire.

Requirements:

The Role:

You will Support Regulatory processes and systems in the production and archiving of Regulatory Submissions supported by the Submission Operations team.

Key Responsibilities:

* Creation, formatting and filing of documents for electronic submissions to ensure that they are “submission ready”, working with Area and Affiliate regulatory personnel.
* Perform pre-publishing tasks to ensure timely set up and maintenance supporting the publishing of regulatory submissions including Registration Management tasks, where applicable.
* Expedite and coordinate a multitude of interrelated activities for a submission team, including Module 1 planners, in the development of published submissions within the required timelines.
* Assist with co-ordination of publishing carried out by offsite contractors, including support for work allocation, resolution of queries and team review.
* Perform post-publishing tasks including organization of submission printing where applicable, to ensure timely despatch and archival of regulatory submissions, and effective maintenance of supporting documentation.
* Liaise and attend meetings with other company functions to meet submission timelines and plans.



Skills/Experience Required:

Education

Life Sciences Degree qualified.

Knowledge

* Experience of working in a regulatory submissions or registration management environment preferred
* Documentum / XML experience preferred
* Essential to work accurately and pay close attention to detail
* Quick to learn new IT systems and processes and the ability to thrive in a changing environment and to re-prioritise workload to meet business needs



If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: or +441753 589673

The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.

Apply for this job: Regulatory Submissions Specialist

Contact Information:

Address:  Head Office
SRG Clinical 9 Devonshire Square London United Kingdom
EC2M 4HP
England
Tel:  +44 (0)203 096 4700
Website:  Visit Our Web Site

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