Adexen Nigeria is recruiting for its client, a leading pharmaceutical company is looking for a Regulatory Affair.
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
- 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.
- 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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