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Job Details

Regulatory Affairs Associate

Company: SRG Clinical
Location: Hertfordshire
Reference: J23767
Closing Date: 26 Oct 17
Type: Part Time
Salary (£): Negotiable
Benefits:

Job Summary:

My Client a Global Pharmaceutical Company has opened a new vacancy within their Regulatory team and is looking to recruit a Regulatory Affairs Associate on an initial 12 month contract to be based in their offices in Hertfordshire.

Requirements:

My Client a Global Pharmaceutical Company has opened a new vacancy within their Regulatory team and is looking to recruit a Regulatory Affairs Associate on an initial 12 month contract to be based in their offices in Hertfordshire.

The Role:

To assist in the preparation of the nonclinical content for various global regulatory dossiers. This role will assist in the preparation of nonclinical regulatory dossiers including:

• Global CTD dossiers for Established Products

• Environmental Risk Assessments (ERA)

• Clinical Trial Applications

Key Responsibilities:

* Completion of periodic updates of the documents to ensure that they reflect a contemporary understanding of each product
* Compilation of specific CTD components from existing submission documentation
* Where necessary, technical authoring of new CTD components to support in licensed/collaborative products.
* Generation of nonclinical submission components to support established pharmaceutical products e.g. Label unification, ad hoc requests for information.
* Authoring and coordinating the nonclinical components of regulatory documents such as Investigator brochures updates.
* Facilitate construction of non-clinical documentation to support applications in China
* Responding to requests for non-clinical documentation in a timely manner
* Coordinating and preparing the nonclinical components of lifecycle documents
* Comprehensive literature/information searches both externally and internally
* Coordination with other disciplines e.g. Nonclinical development and CMC.
* Preparation/review of tabular data summaries and study listings tables for ongoing submission support.





Skills/Experience Required:

Basic qualifications: Minimum graduate level, with a relevant biologically based scientific background.



If you are interested in this role or would like to have a confidential discussion regarding other Regulatory Opportunities. Please contact me: or 01753 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 Associate

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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