Responsible for ensuring the regulatory strategies and regulatory activities are effectively executed to meet the business objectives and legal requirements

• Manage the activities of Regulatory Affairs within the field of responsibility ensuring the implementation of appropriate and effective regulatory strategies in French West Africa

  
  

• Manage and oversee all relevant maintenance activities potentially including Life Cycle management strategy

  
  

• Provide expert regulatory input to strategic decision making; including portfolio review, prioritization, and external communications

  
  

• Provide expert regulatory input to in-licensing evaluations and due diligence activities

  
  

• Provide advice about regulations to manufacturers

  
  

• Coordinate successful submissions and approval of all applications

  
  

• Ensure that quality standards are met and that the deliverables meet strict deadlines and fulfil local regulatory standards

  
  

• Plan, undertake and oversee regulatory inspections

  
  

• Keep up-to-date with changes in regulatory legislation and guidelines

  
  

• Liaise and negotiate with regulatory authorities

  
  

• Review of Promotional Materials

  
  

• Liaise with Supply chain to ensure product availability in the Market

  
  

• Meet BOH officials to ensure important must-win milestones are met

  
  

• Continuous work with local trade associations ensuring best interest for the company

  
  

• Ensure compliance is met for all Regulatory activities

  
  

Qualifications:

• Pharmacist

  
  

• 4-6 years of experience in pharmaceutical industry from a regulatory affairs perspective

  
  

• Knowledge pharmaceutical legislation in French West Africa, relevant guidelines, procedures and requirements

  
  

• Fluent in oral and written Arabic, French and English

  
  

Skills:

• Thorough understanding and demonstrated ability to apply regulatory guidelines/regulations to successful dossier preparation, submission and maintenance

  
  

• Ability to develop innovative strategies and creative solutions within the regulatory context within the scope of global requirements and available resources

  
  

• Strong initiation and organizational skills

  
  

• Outstanding written and oral communication skills, with ability to influence others and negotiate successful

  
  

  
Work Location Assignment: On Premise

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Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.