Regulatory Affairs Associate

January 12, 2022

Job Description

Sanofi Nigeria

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
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.

Application Closing Date
Not Specified.
How to Apply
Interested and qualified candidates should:
Click here to apply online

To apply for this job please visit sanofi.wd3.myworkdayjobs.com.

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