Opening For Submission Team Manager : Ware, Hertfordshire

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Amar Annamalai
Amar Annamalai's picture
Opening For Submission Team Manager : Ware, Hertfordshire

 Basic qualifications: 
 
• Bachelor of Science Degree or equivalent in a relevant Subject (Life Science) 
• Relevant post graduate experience, both scientific and regulatory
• Thorough understanding of pharmacology, toxicology and pharmacokinetics related to drug development
• Thorough understanding of regulatory processes and issues
• Thorough understanding of the regulations relevant to nonclinical development
• Excellent verbal, written, and presentation skills
• Excellent planning and organization skills
 
Preferred qualifications: 
Higher degree or relevant professional qualification, or equivalent practical experience
 
Details: 
NCR is a key member of the regulatory matrix team, acting as the regulatory specialist for all nonclinical work or issues. NCR coordinates and prepares all nonclinical documentation required for global regulatory submissions for both pre and post marketed assets. NCR also coordinate the full FTIH IB authoring process
 
Our work includes: 
Authoring Investigator Brochures (FTIH, post FTIH and supplements) 
Clinical Trials Applications (IND or IMPD) 
Marketing Applications (MAA/NDA, supplements/variations, product line extensions, etc.) 
EU Environmental Risk Assessments 
PIPs 
Briefing documents 
Annual Reports, Drug safety Update reports and Information amendments 
Renewals 
PREPS 
Ad hoc existing business regulatory requests
Closing date for applications: 22nd May 2014

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