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Regulatory Executive - Ware

Hertfordshire   •  £0 - £388 per day  •  Contract/Temporary, Full time

Jennifer Whoolley is recruiting for a Regulatory Executive to join a company in the Pharmaceutical industry at their site based in Hertfordshire on a 12 month contract basis.

As a global healthcare company, our client takes on some of the world's biggest healthcare challenges. By delivering a sustainable business, they provide health benefits to patients and consumers, improved shareholder returns as well as supporting wider society. They have three world-leading businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products. They are committed to widening access to their products, so more people can benefit, no matter where they live in the world or what they can afford to pay.

The position, situated in Ware, is at our clients leading manufacturing site for new product introduction and where they launch new medicines to countries worldwide. There are two Ware sites split between manufacturing and research and development. In total our client employs over 2000 people across the manufacturing and R&D facilities. The Regulatory Executive will be working within the R&D facility.

Ware is set in some of the most beautiful countryside in the Home Counties and is situated 25 miles north of London on the A10 trunk road to Cambridge. There are frequent trains to London Liverpool Street or Tottenham Hale and Ware is served by buses from Hertford , Waltham and by the 724 Green Line from Heathrow Airport to Harlow.

As a Regulatory Executive you will assist in the preparation of nonclinical regulatory dossiers including Global CTD dossiers for Established Products, Environmental Risk Assessments (ERA) and Clinical Trial Applications.

Additional duties include:
·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 GSK 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.
·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 GSK databases).
·Coordination with other disciplines eg Nonclinical development and CMC.
·Preparation/review of tabular data summaries and study listings tables for ongoing submission support.

To succeed in this role, you will have knowledge of nonclinical regulatory requirements and/or environmental risk assessments, a minimum of a BSc with a relevant biologically based scientific background, understanding of pharmacology, pharmacokinetics & toxicology related to drug development and excellent written and verbal communication skills, computer literate and competent in the use of Microsoft Word.

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 KA42723 in all correspondence.

You must be eligible to work in the UK. Learn more

  • Agency: CK Group (Science, Clinical, Engineers and IT Recruitment)
  • Contact: Jennifer Woolley
  • Phone: 01438 743047
  • Reference: KA42723
  • Posted: 6th July 2018
  • Expires: 3rd August 2018
CK Group (Science, Clinical, Engineers and IT Recruitment)

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