Adexen Nigeria Vacancies: Regulatory Affair

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

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

Job 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.

Job 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.

Click here to Apply online: