Karima MENOUS

Regulatory Affairs associate

with a doctorate in pharmacy, i begun my professional journey as a community pharmacist , but my passion for pharmaceutical industry got me to choose my first job in Roche.
Below my main functions:

Drugs regulatory affairs associate and Bio safety Officer
Roche Algeria SPA Roche Diabetes Care Hydra- Alger
Ensuring timely request and submission to Health authorities of all registration items required for registration of new products, new indication, line extensions and monitoring the registration process in order to obtain regulatory approval in due time .
Ensuring timely submissions/ approvals for upcoming product variations and product renewals.
Identifying, requesting and following up on required items for various regulatory activities
Establish an effective communication network with internal partners: interacting with various functions to support business: business development, marketing, pricing, sales, logistics
Using and implementing appropriate SOPs as required by Global policies, local regulations and acceptable good regulatory practices. - - Ensuring the local label creation and packaging development will meet the local and corporate criteria.
Validation of packaging material at the NLCPP. In charge of importation programs applications Compilation of reimbursement application.
As a Bio safety Officer my primary responsibilities are:
Elaborate or adapt the group’s directives in order to ensure biological safety
Update the biological safety programs. Train colleagues exposed to biological risks.
Establish instructions to initiate new collaborators.
Evaluate the risks and define the additional safety measures such as decontamination’s method or solid and liquid waste disposal.
Inspect the building periodically and send a report to the SHE Officer.

Last Resume Update May 5, 2019
Address Algiers, Algeria
E-mail menous.karima@gmail.com
Phone Number 00213770664929

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