Qualifications
At least 2 years of professional experience within Regulatory
Bachelor or higher graduate degree in science-related field
Very good English language skills
Attention to detail and quality of documentation
Effective oral and written communication skills
Ability to work on own with minimal supervision
Good knowledge of global / regional / national country requirements / Regulatory Affairs Procedures with proven experience in at least one of the following areas;
Authoring Chemistry Manufacturing & Control documents for post-approval regulatory submissions, including for European Union and other countries.
Development of product information for post-approval regulatory submissions
Working within Regulatory Information Management systems and submission publishing for electronic submissions to regulatory agencies
Regulatory submission experience in marketing authorisation applications especially for Emerging Markets (Asia-Pacific, Latin America, Middle East, Africa, E Europe)
Basic knowledge in one of the specialist areas; preclinical, clinical, or CMC, etc.
Ability to act as liaison with other departments where necessary (i.e. Project Management, Clinical Supplies, QA, Clinical Management, Data Management, Biostatistics, etc)
Suitable experience working in the pharmaceutical/CRO industry is preferred
Read More
At least 2 years of professional experience within Regulatory
Bachelor or higher graduate degree in science-related field
Very good English language skills
Attention to detail and quality of documentation
Effective oral and written communication skills
Ability to work on own with minimal supervision
Good knowledge of global / regional / national country requirements / Regulatory Affairs Procedures with proven experience in at least one of the following areas;
Authoring Chemistry Manufacturing & Control documents for post-approval regulatory submissions, including for European Union and other countries.
Development of product information for post-approval regulatory submissions
Working within Regulatory Information Management systems and submission publishing for electronic submissions to regulatory agencies
Regulatory submission experience in marketing authorisation applications especially for Emerging Markets (Asia-Pacific, Latin America, Middle East, Africa, E Europe)
Basic knowledge in one of the specialist areas; preclinical, clinical, or CMC, etc.
Ability to act as liaison with other departments where necessary (i.e. Project Management, Clinical Supplies, QA, Clinical Management, Data Management, Biostatistics, etc)
Suitable experience working in the pharmaceutical/CRO industry is preferred
Read More
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