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Job Description
- Preparation of registration & re-registration files of the company products’ (local and imported).
- Assuring the submission of registration & re-registration files according to the schedules declared by the Central Administration of Pharmaceutical Affairs (CAPA) and following-up files submission to various committees until receiving the final registration licenses.
- Preparation and following-up on the inspectors’ visits from the Ministry of Health (MOH) for the following subjects: - Licensing of new production lines & associated stores. - Periodic inspection visits for sampling of new products (Local & Imported), existing products, raw material … etc. - Periodic inspection visits for releasing of imported packaging materials & imported R&D samples.
- Following-up on analysis of new products in the National Organization for Drug Control and Research (NODCAR), until receiving the final conformity of the product and releasing the new products
- Following-up on issuing of all the requested certificates for the Export department. (For example: Free sale, GMP, copy of plant license …. etc.)
- Working closely with Art Work Department in revising drafts and final outer & inner packs data & issuing them from MOH & revising final films, stickers & tubes from printing houses.
- Directing the subordinates on how to carry out all the registration steps and builds business relationships in the Pharmaceuticals Governmental Organizations.
- Coaching the subordinates on achieving their work objectives, solve problems & overcoming all work obstacles.
- Applying the company policies and work for achieving its goals according to the ethics, rules & regulations.
Job Requirements
- B.Sc pharmacy ,Science
- Computer skills
- Legal knowledge
- Management skills
- Administrative skills
- Communication skills, problem-solving skills and strategic planning skills
- 5-6 Years of experience as Regulatory Affairs Manager in Medicated Cosmetic Companies
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