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Regulatory Affairs Manager

ALGER

Catégories: Stratégie & Management
Wilaya: ALGER
Publiée le: 25-12-2023 à 11:08:56

Description

Mission :

Prepare, submit, and ensure appropriate follow-up for new marketing authorization applications with local authorities for assigned products.
Ensure timely submission of modifications, renewal requests, and additional marketing authorizations for authorized assigned products.
Provide timely, accurate, and compliant translations of labeling and illustrations for assigned products.
Continuously ensure compliance with local regulatory requirements as well as company policies and procedures.
Demonstrate clear leadership in shaping the regulatory environment to support subsidiary objectives.
Collect relevant publicly accessible regulatory information (regulatory intelligence) and keep stakeholders properly informed.
Collaborate with the Commercial Affairs team at local, regional, and global levels to support product-related business initiatives.
Facilitate the release of commercial shipments by sending appropriate documents to distributors in a timely manner.
Coordinate labeling activities and work closely with registration managers to ensure timely submissions.
Update all regulatory databases.
Support local activities by reviewing and submitting promotional material and events.
Collaborate with various local departments, including Supply Chain, Market Access, Business, Medical Finance, etc.
Maintain positive relationships with internal and external regulatory contacts.
Continuously ensure compliance with local regulatory requirements and internal policies and procedures.
Provide administrative support to the Regulatory Affairs department to internal and external stakeholders, including the finance department and suppliers

Profil :

Bachelor's degree in Pharmacy.
Over 3 years of experience in the pharmaceutical industry.
At least 2 years of relevant experience in Regulatory Affairs.
Excellent proficiency in French and Arabic.
Fluent in English.
Strong organizational skills.

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