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Regulatory Affairs Specialist - Pasteur & Diabetes

Sanofi
Cairo, Egypt
Posted 4 years ago
132People have clicked1 open position
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Job Details

Experience Needed:
Career Level:
Education Level:
Salary:
Job Categories:

Skills And Tools:

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
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