Executive, Regional RA/QA/PV (12 months Contract)

This position is responsible for supporting regulatory affairs, quality assurance and pharmacovigilance activities for pharmaceutical, medical device andcosmetic products. Ensures compliance with global and regional regulatory requirements, supports product registration strategies, and maintains quality systems aligned with GxP requirements. 1.   Regulatory Affairs Support the implementation of product registration and lifecycle management strategies cross APAC markets. Maintain high-level regulatory knowledge and provide guidance to global counterparts. l  Agency interactions: Acts as core point of contact to relevant authorities/external organizations (CROs, NBs, etc) for products/projects. Liaises, negotiates and lead interactions, including appropriate documentation of the interaction, decisions and outcomes. l  Dossier submissions: independently leads the preparation, coordination or monitoring of regulatory submissions. Interacts across APAC and global to obtain and/or provide information/data for regulatory submissions. l  Coordinates regulatory change control responses from APAC countries and collaborate with Supply Chain department for stock build when required. 2.   Quality Assurance l  Supports the implementation and maintenance of the regional Quality Management System (QMS)in compliance with cGMP and applicable regulatory requirements. l  Coordinate and support day-to-day QA activities in accordance with approved SOPs and company policies, such as but not limited to complaints and adverse event reporting, assessment of shipment temperature excursions, product returns etc. l  Assist in the preparation for and participation in regulatory inspections, certification (e.g., GDPMDS) and customer audits. l  Participates in Quality Management Review Meetings. l  Provide new hire and refresher training for employees to ensure compliance with SOPs l  Maintain a good documentation system and ensure proper record retention. l  Ensure established Quality Management System such as Product Complaint, FSCA, Recall, Internal & External Audits, Vendor Management, Deviation Management, CAPA, Change Control and Quality Risk Management are effectively implemented, monitored and in compliance with cGMP / authority requirements 3.   Pharmacovigilance l  Support day-to-day processing of incoming adverse event reports and reporting to regulatory authorities, with the objective of achieving a high level of regulatory compliance. l  Ensure Pharmacovigilance activities are conducted in accordance with Merz Asia Pacific SOP's, Work Instructions, Safety Data Exchange Procedure (SDEP), Good Vigilance Practice guidelines and relevant regulatory requirements. l  To assist in the preparation and maintenance of Pharmacovigilance documentation, SOPs and preparation for any internal audits or external inspections on Merz Asia Pacific pharmacovigilance function. l  Acts as the deputy PVRloc for Pharmaceutical and Medical Device Vigilance surveillance.