Regulatory Affairs Manager
- الفئات: استراتيجية وإدارة
- المنطقة: الجزائر
- وضع في: 25-12-2023 à 11:08:56
- 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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