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Job Details

Regulatory Affairs Executive

Company: SRG Clinical
Location: Hertfordshire
Reference: J27507
Closing Date: 02 Aug 18
Type: Part Time
Salary (£): Negotiable
Benefits:

Job Summary:

SRG are currently looking for Regulatory Executive for a Global Pharmaceutical Company who have opened a new vacancy within their Regulatory team to be based at their offices in Hertfordshire on an initial 6 month contract.

Requirements:

The Role



Preparation of high quality, Chemistry manufacturing and control (CMC) detailed regulatory documents using varied information sources. Liaising closely with other internal personnel to ensure accuracy of such documents. Working together with other groups to ensure that ongoing projects are captured in these documents and that any changes are recorded. Ensuring that project work proceeds according to agreed deadlines and maintaining status records. Responsible for highlighting potential delaying factors promptly.



Role Specific Requirements



* Detailed proven CMC knowledge and experience for primarily EU but will work within the US market also.
* To support in CTA submissions and prepare high quality dossiers.
* Understands CMC regulations, guidelines, procedures and policies relating registration and manufacturing of pharmaceutical products, to expedite submission, review and approval of global CMC applications.
* Ability to manage multiple project assignments/teams simultaneously and provide data assessment and conclusions
* Identifies improvement opportunities for CMC Regulatory processes, policies and systems.
* Experience in biopharma submissions highly desired



Education

Minimum graduate level, in any life sciences.



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 Affairs Executive

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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