Drug Regulatory Affairs (DRA) Associate at a Multinational Pharmaceutical Company

Posted on Fri 28th Nov, 2014 - hotnigerianjobs.com --- (0 comments)

A multinational pharmaceutical company is recruiting to fill the below position:

Job Title: Drug Regulatory Affairs (DRA) Associate

Location: Lagos, Nigeria
Duration: 6 months Contract

Job Summary

To support the DRA Manager in registration of new drug products and the maintenance of registration of approved drug products in order to ensure viability of these products in the marketplace.
To support DRA Manager in ensuring the timely registration of new drug products and the maintenance of registration of approved drug products in order to ensure viability of these products in the marketplace as well as maintaining the company database to ensure up to 95% compliance level.

Responsibilities
New Product Registrations:

Support the DRA Manager by preparing local dossiers for submission with drug registration applications in a timely manner and in follow up of the application during the evaluation phase to achieve a favourable outcome.

Maintenance of registered products:

Support the DRA Manager in maintaining registration of currently approved products.
Maintaining the database with up to date and accurate information of the products under the supervision of the DRA Manager.
Relationship with Distributors: With minimum supervision, ensures all registration documents required for importation of products are provided to our distributors to ensure compliance.

Relationships outside the company:

Develop and maintain good working relationships with Health Authority.
Provide feedback from Health Authority to the DRA manger while following up on submissions made to the Health Authority.

Requirements/Competencies

Minimum of a Bachelor's degree.
1 - 3 years of practical drug regulatory experience.
Excellent organization skills and the ability to multi-task; detail oriented.
The ability to establish and maintain good working relationships at all levels of the company and with external contacts.
Excellent verbal and written communication skills. Share concepts, ideas, information, and suggestions with management, peers and others.
The ability to provide regulatory assessment to other departments with little or no supervision.

Application Closing Date
12th December, 2014

Method of Application
Interested and qualified candidates should kindly forward their CV's to: [email protected]

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