Regulatory Affairs Associate at Sanofi

Job Requisition ID: R2626732
Grade: N2-1
Job type: Full time
Reports to: Country Regulatory Affairs Head
Department: Regulatory Affairs

Role Responsibilities

• Coordinate dossier and briefing package preparations according to the plans (new registration and maintenance) and monitoring dossiers up to implementation.
• Ensures optimal support to key stakeholders to deliver on-time high quality dossiers in compliance with Health Authority requirements.
• Liaise with HA contact person; organizing and preparing HA meeting and attending as appropriate.
• Manage the maintenance of a portfolio of products.
• Accountable for keeping the databases updated on a timely basis for portfolio he / she is in charge of.
• Provide support and communicating information on products to other functions (approvals, ...)
• Review and validate at country level promotional material with Marketing and Medical in line with Global strategies and policies.
• In liaison with his / her manager, can be involved in activities such as shortages, DHPC, B / R reevaluation, etc.
• Support the consolidation and provision of regulatory expertise and giving input about requirements and needs.
• Follow regulatory changes

Working Relationships

• Internal: Supply Chain; Pharmacovigilance; Business Units
• External: NAFDAC; Distribution Centre and other relevant stakeholders

Requirements
Education and Experience:

• Education: Master's Degree in Pharmacist, Physician, Veterinarian or preferably Life Sciences
• Related Experience: Minimum of 1-3 years’ experience  in similar position  in different types of registrations, preferably in  multinational organization.

Requirements - Professional Knowledge and Skills:

• Negotiation & communication skills
• Organization skills and high accuracy in documentation
• High sense of urgency
• Priority setting and management
• Knowledge of new decrees & guidelines
• Multitasker
• Awareness and adherence to company internal SOPs & compliance standards
• Promptness in respond to authorities requirements and prompt in deliverables
• Analytical skills
• Ability to alert hierarchy in case of specific situation impacting his/her work environment
• Problem solving skills
• Presentation skills
• Interpersonal skills
• An understanding and appreciation of relevant legal, scientific and manufacturing area.