Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
We are recruiting to fill the position below:
Job Title: Regulatory Affairs Associate
Job Requisition ID: R2626732
Location: Lagos, Nigeria
Job type: Full time
Reports to: Country Regulatory Affairs Head
Department: Regulatory Affairs
- 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
Internal: Supply Chain; Pharmacovigilance; Business Units
External: NAFDAC; Distribution Centre and other relevant stakeholders
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
- 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.
Application Closing Date
How to Apply
Interested and qualified candidates should: