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), (Promotionalmaterial 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
Ensuresafety 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
Analyticalskills
Ability to alert hierarchy in case of specific situation impacting his/her work environment
Problem solving skills and sense of anticipation
Presentationskills
Interpersonalskills