Regulatory Affairs Manager

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

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

Catégories: Stratégie & Management

Région: ALGER / ALGERIE

Publiée le: 25-12-2023 à 11:08:56