Regulatory Affairs Manager

The position

As the Regulatory Affairs Manager for the Philippines affiliate, your role encompasses managing regulatory operations including the maintenance of PhFDA License to Operate for drugs and medical devices, overseeing the life-cycle management of product marketing authorizations, and securing timely approvals for new drug or device applications. You are also in charge of staying abreast of regulatory intelligence to ensure compliance with local regulations and providing regulatory support to different departments and teams within the affiliate, aligning with the local business demands. This position reports to the Associate Director for Medical & Regulatory, and this position is a single contributor role. Other role expectations are:Preserve and maintain the affiliate’s license to operate for drug products and medical devices.Manage and supervise regulatory affairs (RA) applications for life-cycle management (LCM).Organize and supervise RA applications for ...