Senior Regulatory Affairs Manager

JOB SUMMARY

The Senior Regulatory Affairs Manager, will lead, manage and provide strategic direction to execute regulatory strategies and plans for the country. 

The Sr Regulatory Affairs Manager reports to the Cluster Lead NWA

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 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 / SKILLS

Qualifications:

• Pharmacist
• Min 7 years of experience in pharmaceutical industry from a regulatory affairs perspective
• Knowledge pharmaceutical legislation in EU, Algeria 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 outcomes.
• Strong analytical skill and technical/ scientific competence
• Attention to details and ability to appropriately assess risks and formulate risk-management.
• strategies, including taking “the big picture” view on various options.
•  Team-player, able to positively influence team members at all levels with an entrepreneurial “can do” attitude.
•  Proactive, quick learner and independent worker able to effectively multi-task in a high-pressure environment and follow issues through to conclusion.
•  Experience from working with medical devices /generics / biosimilars is an advantage.
• IT skills

  
Work Location Assignment: On Premise

#LI-PFE

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

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