Regulatory Affairs Specialist - Pasteur & Diabetes
Sanofi -
Cairo, EgyptPosted 4 years ago132People have clicked1 open position
Job Details
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Job Description
- Plan the review of a new application submission corresponding to company plan as well as the agency guidelines for submission.
- Plan for the review and submission of all the maintenance activities (renewal & variations) based on company plans and the agency guidelines
- Timely implementation of all plans with strict follow up with both internal & external stakeholders for timely achievement of the plan.
- Maintain the products labeling up to date, implementing global and local labeling decisions , through labeling, review and approval
- Updating the internal Sanofi Systems regularly
- Carrying the planned LCM activities and reflecting the approvals on the internal systems
- Revision and approval of promotional Materials any updated packaging material on VISTA
- Preparation, submission and follow up of pricing files internally and externally
- Assure compliance with IA files
- Following and complying with all the defined internal policies and procedures of working
- Following strictly all the Authority Regulations, decisions & decrees
- Carry out all the required communication and follow up required with local affiliate, region & corporate as appropriate.
- Carrying the planned Activities and reflecting the approvals on the internal system
- Revision and approval of Promotional Materials & any updated packaging material.
Accountable for timely Batch release for vaccines & related activities:
- Analysis requirements management (In-house, commercial,..etc).
- Overprinting
- Cold chain follow up & reporting
- Response to HA questions within the scope of batch release.
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 Requirements
Education:
Pharmacist, Physician, Veterinarian
Related Experience:
Up to 3 years of experience in regulatory affairs is a must.
Special Knowledge/Skills:
- Negotiation & communication skills
- Organization skills and high accuracy in documentation
- High sense of urgency. Priority setting & management. Multi-tasker
- Awareness and adherence to company internal SOPs & compliance standards
- Promptness in respond to authorities’ requirements and prompt in deliverables
- Analytical skills. Problem solving skills
- Presentation skills & Interpersonal skills
- Ability to alert hierarchy in case of specific situation impacting his/her work environment
LEAD competencies:
Act for Change, Strive for results, Cooperate Transversally, Commit to Customer
“Desirable” / compromise experience
- Experience is preferable in multinational organization
- Knowledge of new decrees & guidelines
- An understanding and appreciation of relevant legal, scientific and manufacturing area