Job title: Regulatory Site Section Head

About the Job:

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Your job, as Regulatory Site Section Head within our Manufacturing and Supply Team will be co-ordinate between M&S and DRA departments in regulatory aspects of chemistry, manufacturing, and control for pharmaceutical products. Also managing the regulatory aspects of the change control requests in accordance with the directive and guideline and managing 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.

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 Degree in Pharmacy

Related Experience:

• 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.

Special Knowledge/Skills

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

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

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch our ALL IN videoand check out our Diversity Equity and Inclusion actions at sanofi.com!