CW-Sr Associate Regulatory Affairs Maghreb

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