Job Description

JOB SUMMARY Responsible for ensuring that regulatory strategies and regulatory activities are effectively executed to meet the business objectives and legal requirements JOB RESPONSIBILITIES Manage the activities of Regulatory Affairs within the field of responsibility ensuring the implementation of appropriate and effective regulatory strategies 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 Health Authorities officials to ensure important must-win milestones are met Continuous work with local tradeassociations ensuring best interest for the company Ensure compliance is met for all Regulatory activities

QUALIFICATIONS / SKILLS Qualifications : Pharmacist 5 years of experience in pharmaceutical industry from a regulatory affairs perspective Knowledge pharmaceutical legislation in EU, Morocco and 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 IT skills

ORGANIZATIONAL RELATIONSHIPS

Report to the head of Regulatory Affairs. Interaction with cross-functional department team members and Manager levels will be frequent.

Interaction with Health Authorities will be frequent

Work Location Assignment: Flexible

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

Regulatory Affairs

#LI-PFE

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