Regulatory Affairs Associate At Pfizer
Contribute to the completion of project milestones and organize own work to meet project task deadlines.
Ensure compliance of the team to the submission standards, procedures and policies framed by Global/ AfME Regulatory Affairs.
Responsible for the preparation and finalization of Regulatory Documents (CTD) sections of supplements / variations for Lifecycle Management (LCM) submissions and ensure effective data presentation and quality, by self or under guidance.
Provide regulatory support to the cross functional teams for the assigned products, participates and provides inputs in technical reviews and strategic discussions on regulatory submissions.
Provide regulatory inputs for the approval of promotional materials following applicable regulatory requirement, Pfizer policies, procedures, and practices.
Identify and assess regulatory risks associated with assigned projects and timely communication to the team to quickly mitigate the risks.
Liaise with key stakeholders to ensure the filing strategies are defined and executed, and Board of Health (BoH) requirements are met, ensuring a submission ready dossier.
Ensure commitments made to health authorities are entered into tracking systems and are tracked to closure.
Manage continuous improvement of selected processes relating to Human health submissions and selected drug and non-drug specific projects and related activities.
Ensure timely approval according to product registration plan.
Maintain the required regulatory databases to ensure compliance.
Keep abreast of the external regulatory environment, including competitor intelligence, local product and international regulatory and commercial strategies.
Bachelor’s Degree – Scientific Background
Proven ability to manage complex regulatory or drug development issues
Knowledge of the regulations and guidelines in Egypt market
Strong relationship with the local health agency and other relevant stakeholders and pro-actively manages issues with key external stakeholders
Good skills on communication, collaboration, negotiation and problem solving
Fluent in English, written and spoken
Computer literacy and ability to learn new systems
Knowledge of regulatory processes and documents, knowledge of therapeutic areas
Thinks strategically with good project management skills
Hands on Experience on the Job