Regulatory Associate - Hertfordshire

£25 per hour
09 Jul 2019
08 Aug 2019
Julie Marshall
Regulatory Affairs
Full Time
Contract Type
Experience Level
Experienced (non-manager)
CK Group are recruiting for a Regulatory Associate to join a company in the pharmaceutical industry at their site based in Hertfordshire on a contract basis for 7 months. The rate of pay is up to £25 per hour PAYE.
The Company:
Our client is a global healthcare company who take on some of the world's biggest healthcare challenges. They provide health benefits to patients and consumers and have three world-leading businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products.
The Location:
This role is located on a state of the art R&D facility based in Ware, Hertfordshire. The town lies on the north-south A10 road which is partly shared with the east-west A414 (for Hertford to the west and Harlow to the east). Trains run from London Liverpool Street to Ware and take approximately 45 minutes.
The Role:
To assist in the preparation of the nonclinical content for various global regulatory dossiers.

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.
• Comprehensive literature/information searches both externally and internally (specified company databases).
• Where necessary, technical authoring of new CTD components to support in licensed/collaborative products.
• Generation of nonclinical submission components to support established pharmaceutical products eg Label unification, ad hoc requests for information.
• Collaboration with nonclinical development and regulatory groups.

Clinical Trial Applications: The timely and accurate delivery of regulatory dossiers for the approval and maintenance of product marketing and clinical trials applications must conform to the regulations and guidance of the authority to which the submission is made. This role involves the efficient production of submission documents such that the correct materials are available at the optimum time by:
• Authoring and coordinating the nonclinical components of regulatory documents such as Investigator brochures updates.
• Facilitating construction of nonclinical documentation to support applications in China.
• Responding to requests for nonclinical documentation in a timely manner.
• Coordinating and preparing the nonclinical components of lifecycle documents.
• Comprehensive literature/information searches both externally and internally (specified company databases).
• Coordination with other disciplines eg Nonclinical development and CMC.
• Preparation/review of tabular data summaries and study listings tables for ongoing submission support.
Other nonclinical regulatory supporting tasks that may be required from time to time.

Your Background:
• Minimum graduate level, with a relevant biologically based scientific background.
• Understanding of pharmacology, pharmacokinetics & toxicology related to drug development
• Excellent written and verbal communication skills, computer literate and competent in the use of Microsoft Word.
• Proficiency in searching on-line scientific publication databases.

Preferred qualifications:
Knowledge of nonclinical regulatory requirements [e.g., Common Technical Document (CTD) guidelines] and/or Clinical Trials Applications.
Specific Accountabilities and Responsibilities

This role will assist in the preparation of nonclinical regulatory dossiers including:
• Global CTD dossiers for Established Products
• Clinical Trial Applications

Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.

CK Group is an Equal Opportunities employer and 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 46017 in all correspondence.