Job Description

Key Responsibilities:
1. 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 Regulatory Affairs.
Responsible for the preparation and finalization of Global Regulatory Strategy Documents (GRSD), Comparative Toxicogenomics Database (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.