Health jobs:Wanted Regulatory Affair Expert

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Regulatory Affair
Job reference No: NGA0318
Sector: Health - Nigeria - Western Africa

Our client
A leading pharmaceutical company is looking for a Regulatory Affair.
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Job description
The ideal candidate must have a first experience in a similar position in an Industrial company.
She/ he will ensure the appropriate licensing, marketing and legal compliance of company products in order to ensure their safety and efficiency.
The position is based in Lagos, Nigeria
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Responsibilities
• Responsible for the NAFDAC, SIBN JMP Compliance.
• Keeping abreast of international legislation, guidelines and customer
practices;
• Collecting and collating a wide range of information;
• Keeping up to date with a company's product range;
• Developing and writing clear arguments and explanations for new product
licenses and license renewals;
• Preparing submissions of license variations and renewals to strict
deadlines;
• Monitoring and setting timelines for license variations and renewal
approvals;
• Writing clear, accessible product labels and patient information leaflets;
• Planning and developing product trials and interpreting trial data;
• Advising scientists and manufacturers on regulatory requirements;
• Project managing teams of colleagues involved with the development of new
products;
• Undertaking and managing regulatory inspections;
• Reviewing company practices and providing advice on changes to systems;
• Liaising with, and making presentations to, regulatory authorities;
• Negotiating with regulatory authorities for marketing authorization;
• Specifying storage, labeling and packaging requirements.
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Qualifications et experience
• Bsc or Msc as Pharmaceutics
• Must be a qualified regulatory affair.
• At least 3/5 years experience in a similar position.
• Be personable and of high integrity.
• Ability to work in multicultural environment and under pressure.
• Fully fluent in spoken and written English.
• Corporate presentation, excellent interpersonal skills.
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What is on offer
Attractive package

APPLY HERE

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