Adexen Nigeria Vacancies: Regulatory Affair

Posted on :

18 Feb, 2010

Category :

Pharmaceutical Jobs in Nigeria

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:

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