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Job Details

Senior Associate Regulatory Affairs / Junior Manager of Regulatory affairs

Company: TEC Group International
Location:
Reference: samgerm
Closing Date: 18 Dec 16
Type: Permanent
Salary (£): 60,000 - 80,000
Benefits:

Job Summary:

The consultant running this executive search is Sam Murphy. For more information or to apply to the position please contact Sam via email – sam.murphy@tecgroup.net

Requirements:

TEC Group is currently partnered with a global CRO that has established a strong and reputable name in the global market.

The position will demand a good knowledge of global clinical trial submissions and fluent in German and English

A solid background submitting clinical trial documentation is essential for this position as you will be leading a team of Regulatory associates. This position is a full-time, office-based Regulatory coordinator to join one of the leading Clinical Operations teams in Germany.

The company is a big believer in empower the teams to employ their unique talents and experience to take an assertive approach to research, problem solving, and ultimately supporting our partners.

 

Duties

• Prepare, review, and file initial clinical trial applications to regulatory authorities and Ethics committees in Germany, Austria and Switzerland;

• Prepare and submit responses to queries and amendments to clinical trial applications;

• Ensure submissions comply with applicable regulations and guidance documents;

• Advising sponsors on changing regulations and compliance requirements;

• Track submissions and ensure timely filing of documents;

• Collecting essential documents and preparation essential documents packages for drug release.

Requirements

• Bachelor's degree in life sciences;

• Hands-on experience preparing, reviewing, and submitting regulatory documentation;

• Experience as a Regulatory Submissions Coordinator or Regulatory associate (Clinical trials)

• Minimum 4 years’ experience for the Regulatory position.

• Fluency in English and German language. Compensation Package 

The company offers a competitive salary and package that is higher than the market average. Some of the position benefits include a company car, pension, premium health care and a shares scheme from day one. A full progression ladder is offered to show the natural progression within the role while allowing a creative platform for the selected candidate to choose areas of expertise. While the company continues to grow they would like to offer more flexibility to the position that could lead to a flexible work life balance. 

Apply for this job: Senior Associate Regulatory Affairs / Junior Manager of Regulatory affairs

Contact Information:

Address:  Head Office
Dowgate Hill House, 14-16 Dowgate Hill, London
EC4R 2SU
England
Tel:  +44 (0) 208 544 3400
Website:  Visit Our Web Site

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