Career Category

Job Description

Key responsibilities:

• Planification, preparation, submission to HA and, follow up of the RTQ and the approvals of the variations, renewal and new application dossiers
• Review and dispatch variation, new application and renewal dossier to distributors and ensure submission
• Knowledge of the registration process and local regulations
• Responsible of file publishing to regional distributor
• Follow up submission and approvals with distributors (Morocco and Tunisia)
• Dispatch LOQ from regional HA to global teams and follow up on RTQ, dispatch RTQ once provided to distributor and ensure submission and approvals.
• Carrying the planned LCM activities and reflecting the approvals on the internal systems
• Interact with Health authorities / Represent Amgen. (Algeria)
• Provides guidance for regulatory requirements of variations (CMC, Labelling, admin…)
• Responsible for review and validation of promotional and non-promotional material, declaration of PM and non PM to Health authorities, and follow up to get approvals. (Algeria,  Morocco and Tunisia), (Promotional material Lead)
• Responsible for training staff on promotional and non-promotional material SOP
• Provides guidance for regulatory requirements of new application requirements
• Provide support and regulatory guidance to cross functional department   
• Accountable for documenting variations (CMC, Labelling, administrative…) submissions and related communications; archiving documents in document management systems
• Interacts with RRL, Intercontinental CMC teams to ensure the filling of regulatory requirements per country for variations and renewal
• Responsible to review local labelling to compile with local requirements
• May participate in cross-functional special project teams.
• Provide country product & regulatory expertise, oversight & guidance;  
• Involved in redacting SOP when relevant
• Regulatory intelligence updates;  
• Advocates and actively supports regulatory/safety compliance
• Decisions on implementation of regional CMC strategic objectives
• Ensure safety back up

              Qualifications

• Pharmacist/ Pharm D pharmacy
• A minimum of 2 years related experience in pharmaceutical/biotechnology, Regulatory Affairs in multinational industry.

  Professional Knowledge and skills        

• Confidentiality and accountability.
• Negotiation & communication skills
• Organization skills and high accuracy in documentation
• High sense of urgency
• Priority setting and management
• Multitasker
• Analytical skills
• Ability to alert hierarchy in case of specific situation impacting his/her work environment
• Problem solving skills and sense of anticipation
• Presentation skills
• Interpersonal skills
• Ability to plan and implement actions to achieve objectives.
• Ability to resist potential pressures and crises.
• Network of customer contacts.