Regulatory Affairs Associate

Responsibilities:

• 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.