Regulatory Site Officer (RSO) Specialist

Job title: Regulatory Site Officer (RSO) Specialist

Location: Cairo Site

Grade: L1-2

Hiring Manager: Moreen Mamdouh - Regulatory Site Section Head

About Sanofi:

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

About the job

Job Purpose

To ensure timely and compliant submission of pharmaceutical product registration files to the Egyptian Drug Authority (EDA), manage ongoing regulatory relationships with inspectors, and coordinate cross-functional activities to maintain product approvals and close regulatory gaps.

KEY RESPONSIBILITIES AND DUTIES:

Preparing the registration files in coordination with DRA department during new registration or re-registration:-

• Preparation of IA part of regulatory files (Products Renewal)
• Reviewing of IA part of regulatory files (New Products)
• Regulatory compliance checking (Gap analysis)
• Review & Approval of updated method of analysis from QC 
• Revising stability data, gathering raw material specifications, printed packaging materials.
• Send updated data to DRA with samples of finished products, with their certificates.
• Managing of submission of variations to DRA to be submitted to EDA to close any identified regulatory GAPs found.
• Initiate the CTD file for local and exported products.

Managing regulatory activities with the EDA inspector

• Receiving of all the new EDA decisions & informing the concerned departments for implementation.
• Managing the release of certain products with the EDA inspector.
• Following Raw materials & finished products sampling with the EDA inspector on weekly basis

HSE Responsibilities:

• Ensures HSE approval on any SOP that requires certain HSE precautions.
• Ensures HSE approval on any change.
• Follow the laboratory safety procedures
• Commitment to the appropriate PPE use.
• Follow the approved HSE policy and requirements.
• Following the statutory legislation concerning Health, Safety and environmental law.
• Hydrocarbons/ hazardous substance & waste segregation in accordance with approved waste management system.

Others:

• Perform other duties as assigned.
• Respect of company’s values, code of ethics and social charter.
• Respect of personal data protection charter.
• Responsible for applying the HSE related requirements for the company in all related working procedures.

JOB-HOLDER’s ENTRY REQUIREMENTS:

Education:

• Bachelor of Pharmacy.

Related Experience:

• 2+ years' experience
• Regulatory activities experience is highly preferred.

Special Knowledge/Skills:

• Communication & Presentation skills
• Computer skills
• Sense of urgency & Follow up skills
• Time management skills, High organization & planning skills
•  Good Command of English Language
• Attention to Details
• Hard Worker and Team Worker

competencies:

• Stretch to go beyond the level we have operated at up until now
• Take actions instead of waiting to be told what to do
• Act in the interest of our patients and customers
• Put the interests of the organization ahead of my own or those of our team
• Act for Change, Strive for results, Cooperate Transversally, Commit to Customer
• Think Strategically, Lead Teams, Develop People, Make Decisions.

Why choose us?

• Help shape the future of care for chronic and complex conditions like Immune, diabetes and cardiovascular disease - and make a real impact at scale, with medicines that reach over 100 million people each year.

• Lead a high-impact portfolio with bold ambitions and significant upcoming launches.

• Drive meaningful change in a streamlined, AI-powered organization that values smart, modern ways of working.

• Expand your leadership impact through cross-functional collaboration and international career paths