Regulatory Site Section Head At Sanofi
Co-ordinate between Industrial Affairs department and DRA department in regulatory aspects of chemistry, manufacturing and control for pharmaceutical products.
Manage the regulatory aspects of the change control requests in accordance with the directive and guideline.
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)
Re-organization of registration dossiers
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 CTD 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.
Regulatory Compliance Maintenance & Product Maintenance Program
Setting of regulatory compliance annual plan.
Ensure regulatory compliance assessment is performed according to the plan.
Update the regulatory compliance status on quarterly basis.
Ensure escalation of regulatory compliance gaps as per defined procedures to the concerned responsible person.
Reporting of the regulatory compliance KPIs to QO head.
Issue and Follow up the product maintenance plan of the site with the concerned department.
Site Master File Update
Ensure the Site Master file is updated frequently as per defined plan in the procedures.
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.
Bachelor of Pharmacy.
6-8 years of experience, in a related position.
Experience in manufacturing processes, qualification and validation activities, method of analysis techniques.
Basic GMP rules, Stability studies assessment and MOH regulations.
Managing of global and local projects.
Managing people as previous experience will be an asset.
Communication skills, 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