Regulatory Site Specialist At Sanofi Egypt
Co-ordinate between Industrial Affairs department and DRA department in regulatory aspects of chemistry, manufacturing, and control for pharmaceutical products.
Manage the regulatory activities with the Ministry of Health Inspection Department.
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 MOH to close any identified regulatory GAPs found.
Initiate the eCTD file for local and exported products.
Managing regulatory activities with the MOH inspector
Receiving of all the new MOH decisions & informing the concerned departments for implementation.
Managing the release of certain products with the MOH inspector.
Following Raw materials & finished products sampling with the MOH inspector on weekly basis
Support in PQR preparation for regulatory chapter
Prepare the regulatory chapter in PQRs.
Management of Regulatory compliance activities:
Perform regulatory compliance assessment for products dossiers.
Put regulatory compliance action plan for the detected gaps.
Follow-up for findings action plan execution.
Final Authorization of Products specifications and Method of analysis Preparation of site master file, site management registration in MOH process. 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.
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.
Education: Bachelor of Pharmacy.
Related Experience: (3-5 years` experience) Knowledge of regulatory activity and MOH registration regulations in addition to quality background.
Communication skills, Presentation skills, Computer skills, Sense of urgency, Follow up skills, Time management skills, High organization & planning skills, Good Command of English Language, Good computer skills, Attention to Details, Hard Worker, and Team Worker
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