Registration specialist

Job title: registration specialist reports to: registration manager

Job code: date: \ \ department: registration

Salary grade:

Job summary

Prepare everything related to the preparation of the registration

company's files (pharmaceutical & medicines), even access to final
registration file and get notified Date (notified registration no).

Main responsibilities

1. To prepare the (pharmaceutical & medicines) registry files

which include the flowing steps,
- Preparation of (pharmaceutical &medicinal) documentation
such as ( Product Composition index - analysis certification
– analysis method - pharmaceutical stability study ) which
prepared by a pharmacist
2. Provide the registry files of the Central Pharmaceutical Affairs
in order to get notified Date.
3. follow up any observations of the parties, which will be to
register about pharmaceutical product to do and modified it
to meet the registration requirements
4. Prepare the product category type
5. Prepare the internal compendium of the product (In English
and Arabic) And compliance (the known pharmaceutical
standard products ) with required registration of the
pharmaceutical product
6. To prepare the clinical studies of the product, to know
Pharmacological therapeutic or interventions.
7. To prepare the pharmacology study
8. Address research centers to prepare (Research study required
& Bioequivalence) of the pharmaceutical product to find out
the financial offer and the required time period.
 9. Formatting the registration file in terms of (spacers – cm)
which depend on the type of category.
10. Provide registration file which include the flowing steps
- Query phase (inquiry) with active ingredient
- Naming preparation phase
- (Pricing) to determine the price of the product and follow
its procedures, whether accepted or rejected.
- Processing (product prospectus and the degree of stability
of the product) for Pharmacology
- The stage of determining the stability of the product to get
the approval of the stability
- Preparation the final registry file to Meets with all the
procedures and requirements for determining the date of
approval & get notified Date or registry no.
11.prepare all the documents Apply to the( Institute of Nutrition)
which include:
- Prepare contracts requirements (Prepare contracts
requirements (factory license - health certificate - storage
devices - GMB)

Knowledge and skills requirement

1- Computer skills (MS office application)

2- language (English) excellent
3- communication skills

Work condition

Working conditions are normal for outside office environment

Physical demands

Limited to those normally associated with clerical jobs (sitting –standing

–walking)

Top management signature:

Reviewed with employee: