Company: CK Clinical
Closing Date: 15 Nov 16
Salary (£): 60,000 - 80,000
Mary Tilston is recruiting for a Regulatory Associate to join a science-led global healthcare company at their site based in Ware on a 12 month...
Mary Tilston is recruiting for a Regulatory Associate to join a science-led global healthcare company at their site based in Ware on a 12 month contract basis.
The main purpose of the role will be to:
-Assist in the preparation of the nonclinical content for various global regulatory dossiers such as global CTD dossiers for established Products, Environmental Risk Assessments (ERA) and Clinical Trial Applications.
-Provide support for the company's extensive portfolio of established products via update of a repository of modular nonclinical regulatory documentation stored within a document management system for the purpose of generating dossiers to support a wide range of regulatory submissions.
-Ensure continued preservation and updating of established product dossiers by completion of periodic updates of the documents to ensure that they reflect a contemporary understanding of each product as well as the compilation of specific CTD components from existing submission documentation.
Further responsibilities will include:
-Generating nonclinical submission components to support established pharmaceutical products eg Label unification and ad hoc requests for information.
-Supporting the preparation of ERA documents which are required under the European Medicines Agency Regulation on Marketing Authorization Applications (MAAs), product line extensions, and license variations (EMEA/CHMP/ SWP/4447/00) or as requested by a non-European Union Agency to fulfil country specific requirements.
-Ensuring the timely and accurate delivery of regulatory dossiers for the approval and maintenance of product marketing and clinical trials applications.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
-Educated to degree level in life sciences or a relevant field with experience in a similar role and experience in regulatory affairs.
- Knowledge of nonclinical regulatory requirements [e.g., Common Technical Document (CTD) guidelines] and/or environmental risk assessments would be preferable but not essential.
This is an excellent opportunity to join a science-led global healthcare company in the pharmaceutical field.
CK Clinical is an Equal Opportunities employer who welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL37352 in all correspondence.
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