Senior Regulatory Affairs Associate - ROW Markets (Contract)

Cambridgeshire  ‐ Onsite
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Keywords

Description

This contract opening is with a research-based pharmaceutical company with a strong pipeline in multiple therapeutic areas and a strong record of product launches in the last few years.

The role itself involves:

- Management of CTA submissions for ROW regional trials
- Preparation of ROW dossier for therapeutically focused products, including repurposing and preparing Module 2 documentation
- Maintenance of the core dossiers for approved products within a specified therapeutic area

To be considered for this opportunity, the following experience is required:

- EU or US regulatory experience (ROW market knowledge not essential)
- Knowledge of CTD structure
- Excellent English language and spoken/written communication skills
- A willingness to be challenged in a fast-paced environment
- CTA submission experience desirable

To express interest in this position please apply through the site or send your CV directly to Andrew at (see below)

Allegis Group Limited and Aston Carter Limited operate Employment Businesses and Agencies and are companies within the Allegis Group Inc. group of companies, the fourth largest staffing company in the world, (collectively referred to as the "Allegis Group"). TEKsystems and Aerotek are divisions of Allegis Group Limited. Applicant data will be treated in accordance with the Allegis Group's Privacy Notice. By submitting personal data to any company or division within the Allegis Group, the applicant is providing explicit consent to the use of such data by the Allegis Group and to the transfer of such data to and from the Allegis Group companies within the UK, Europe and outside the European Economic Area in connection with the fulfilment of the applicant's voluntary requests, and the fulfilment of other job opportunities that match the applicant's profile, and confirms that they may be contacted about such job opportunities.

Start date
April/May 2015
Duration
12 months
From
Aerotek
Published at
13.03.2015
Project ID:
867656
Contract type
Freelance
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