Description: We are looking for an experienced Regulatory Affairs specialist with in-depth knowledge of ASEAN Regulatory requirements in the Registration of pharmaceuticals, medical devices, food supplements marketing authorization and licenses. Knowledge in implementation of pharmaco-vigilance will be an advantage. Quality experience in interacting with Center for Drug Regulation and Research (CDRR), Center for Food Regulation and Research (CFRR) etc. Duties and Responsibilities: You will be in-charge of all regulatory issues and affairs related to the company and different regulatory bodies with respect to the products assigned under your responsibility. Communicate and coordinate with all manufacturing partners/suppliers with based on local FDA guidelines on product registrations or other pertinent issues as applicable. Coordinate and communicate with the concerned quality control and/or regulatory officers of manufacturing partners/suppliers to ensure adherence to mutually acceptable quality standards for the product as required to be complied by FDA Philippines Knowledge and skill in review of Product's Technical Dossiers (CTD) and other pertinent documents and issues related to product registration with FDA Philippines. Proficiency in research and analysis for information and issues related to product specific knowledge if necessary is expected. Create and maintain proactively an updated database of all product registrations and licenses as necessary for renewals and submit the necessary requirements ahead of time. Act as the authorized pharmacovigilance officer for the company by actively coordinating the issues of product complaints/quality with the end-user and or regulatory authorities, maintain updated log for submitted product complaints etc. Represent the company in various FDA sponsored activities, public hearings and seminars as necessary. Qualifications: Bachelor's degree in Pharmacy advanced degree may be beneficial. Several years of experience in regulatory affairs, preferably in the relevant industry or a related field. Excellent communication and interpersonal skills, with the ability to collaborate effectively across departments and with external stakeholders. Detail-oriented with strong analytical and problem-solving skills. Ability to manage multiple projects simultaneously and prioritize tasks effectively. Ability to communicate and interact with different agencies and hospital accounts Knowledgeable on the process of inclusion and documentation in Philippine Hospitals Nationwide Requirements: TOR or Diploma Employment Certificate, if available four copies of 1x1 and 2x2 white background picture Birth Certificate or Passport Valid NBI or Police Clearance Tin Card or Tin Number SSS Card or E1 form Pagibig ID or Pagibig form Philhealth ID or Philhealth form Marriage Certificate if applicable Any two valid ID for opening of China Bank Payroll Account Medical Examination with fit to work to be conducted by our accredited medical clinic Skills: (Not indicated)