ADEXEN Pharmaceutical - Regulatory Affair

REGULATORY AFFAIR
JOB REFERENCE N°: NGA0318

SECTOR: HEALTH - NIGERIA - WESTERN AFRICA

FUNCTION: OTHER

OUR 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

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.

QUALIFICATIONS & 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.

WHAT IS ON OFFER
Attractive package

If your experience, personal characteristics and qualifications meet the position specifications and your personal objectives are to seek such a challenge, then we would like to hear from you with details of your current earnings, up to date CV and explanation as to why your achievements to date fit you for consideration.
CLICK HERE TO APPLY