Regulatory Site Specialist At Sanofi Egypt
Job Purpose:
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
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 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.
Ensure from complying with all legal and Sanofi-Aventis requirements.
Lead his/her team to implement the HSE & EnMS PASS.
Train his/her team on HSE & EnMS procedures, SOP’s and MSDS.
Report any accidents/incidents in his/her area to the HSE department.
Lead his/her team for investigate accidents/incidents to define the root cause.
Support the area manager for takes the corrective and preventive actions to eliminate reoccurrence of any Environmental or Energy nonconformance.
Support the area manager for takes the corrective and preventive actions to eliminate reoccurrence of any accident/incident.
Sharing for HSE / EnMS inspection program, take the corrective actions for any violations in his/her area.
Lead the team of his/her area for doing full risk assessment and Environmental aspects studies.
Define and control the required PPE’s for his/her area.
Define the list of CMR and it’s operational control for Quality labs and production areas.
Control the first aid kits in his/her area.
Leading his/her team for control the significant hazards /aspects and Energy use.
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.
HSE Responsibilities in case joining HSE Excellence team:
Facilitate and guide the employees to implement the HSE&En. Policies. Implement all applicable standards and guides of Sanofi-Aventis in his/her area. Ensure from complying with all legal and Sanofi-Aventis requirements. Lead his/her team to implement the HSE & EnMS PASS. Train his/her team on HSE & EnMS procedures, SOP’s and MSDS. Report any accidents/incidents in his/her area to the HSE department. Lead his/her team for investigate accidents/incidents to define the root cause. Support the area manager for takes the corrective and preventive actions to eliminate reoccurrence of any Environmental or Energy nonconformance. Support the area manager for takes the corrective and preventive actions to eliminate reoccurrence of any accident/incident. Sharing for HSE / EnMS inspection program, take the corrective actions for any violations in his/her area. Lead the team of his/her area for doing full risk assessment and Environmental aspects studies. Define and control the required PPE’s for his/her area. Define the list of CMR and it’s operational control for Quality labs and production areas. Control the first aid kits in his/her area. Leading his/her team for control the significant hazards /aspects and Energy use.
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: minimum of 3 years' experience
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
Knowledge of regulatory activity is a plus
Play To Win behaviors:
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