Regulatory Science Manager French West Africa page is loaded

Regulatory Science Manager French West Africa

locationsAlgeria - AlgiersTunisia - Tunis time typeVollzeit posted onHeute ausgeschrieben job requisition id4907592 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.
Regulatory Affairs