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Regulatory Affairs Associate - CTA - Oncology

Regulatory Affairs Associate - CTA - Oncology

Posted 1 October 2018 by NonStop Recruitment
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Regulatory Affairs Associate - CTA - Oncology

A leading Pharmaceutical Company are seeking to appoint a Senior Regulatory Affairs Associate on a 12 month contract. Ideally they are looking for someone who has 1 years experience working with Clinical Trial Applications in Europe, this position is based within their Oncology Team. A Great opportunity to gain exposure into a new therapeutic area or even work for an international well known company, which gives you a chance to enhance your skill set.

Key Responsibilities:

*Provide and maintain CTA/MA documentation (e.g. variations, substantial amendments, PDCO annual reports) in collaboration with Regional Regulatory Lead
* Prepare regulatory packages and cross-reference letters to support investigator sponsored studies
* Actively support regulatory compliance, and ensure compliance via timely submissions to regulatory agencies
* Create and maintain product regulatory history documents through company systems and appropriately archive all regulatory documents and agency communications
* Review regional component of the Global Regulatory Plan and provide input to operational

Call me Jasmine Sahota at Nonstop Recruitment now for a confidential conversation. Contact me on

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Please send your CV in word format OR if this does not sound like the opportunity for you, but you are a clinical research professional within the pharmaceutical, medical device or biotech industry, please feel free to get in touch, to see other opportunities we may have within this field.

NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland and the Czech Republic and we hold labour leasing licences across Europe. Please visit our website for a full list of the niche markets we cover.

Reference: 36239871

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