Job purpose:
• The Regulatory Specialist will report to the Regulatory Team Lead – Sanofi Pasteur, Diabetes & Sudan.
The Regulatory Specialist will be responsible for managing products under development & maintenance activities.
Specific requirements and responsibilities include:
• According to the Blue Print initiative, Develop regulatory strategy and provide regulatory expertise within project/product teams for products under development and/or marketed products,
• Interface with various project/product teams.
• Coordinate dossier and briefing package preparations according to the plans (new registration and maintenance) and monitoring dossiers up to implementation.
• Ensures optimal support to key stakeholders to deliver on-time high quality dossiers in compliance with Health Authority requirements.
• Liaise with HA contact person; organizing and preparing HA meeting and attending as appropriate..
• Manage the maintenance of a portfolio of products.
• Accountable for keeping the databases updated on a timely basis for portfolio he/she is in charge of.
• Provide support and communicating information on products to other functions (approvals, ...).
• Review and validate at country level promotional material with Marketing and Medical in line with Global strategies and policies..
• In liaison with his/her manager, can be involved in activities such as shortages, DHPC, B/R reevaluation, etc.
• Support the consolidation and provision of regulatory expertise and giving input about requirements and needs.
• Follow regulatory changes, competitor’s status and assess potential impact on daily activities and project strategy.
Key responsibilities & duties:
- 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 entry requirements:
Key “MUST HAVE” competencies, skills & experiences
Education:
o Bachelor of Pharmacy, medicine or Veterinarian
Related Experience:
o Up to 3 years of related experience in the regulatory affairs field
Special Knowledge/Skills:
o Negotiation & communication skills
o Organization skills and high accuracy in documentation
o High sense of urgency. Priority setting & management. Multi-tasker
o Awareness and adherence to company internal SOPs & compliance standards
o Promptness in respond to authorities’ requirements and prompt in deliverables
o Analytical skills. Problem solving skills
o Presentation skills & Interpersonal skills
o Ability to alert hierarchy in case of specific situation impacting his/her work environment
LEAD competencies:
o Act for Change, Cooperate Transversally, Develop Self/People
“Desirable” / compromise experience
- Experience is preferable in a multinational organization
- Experience in handling biological products
- Knowledge of new decrees & guidelines
- An understanding and appreciation of relevant legal, scientific and manufacturing area
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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