YOUR TASKS AND RESPONSIBILITIES : 

• Support in the operational and/or administrative preparation and submission of products for renewal and New Product Development (NPD) applications, new indications, new presentations, new manufacturing site and variations to FDA for drug, food supplements, cosmetics, medical devices and other products and follow through from submission to approval with close supervision from RA Manager/Sr. RA Pharmacist.
• Handle FDA applications and other regulatory activities such as:
  1. Dossier compilation, review, submission and follow-up with FDA
  2. Labeling activities – artwork preparation, mock-up review, submission, follow-up and implementation
  3. Promo Permit applications and approvals
• Update and maintain regulatory database, files and tracking sheets.
• Responsible for the archiving of all relevant documentation in the appropriate system.
• Interacts with local team to obtain information required for submission to FDA and provide regulatory documents and/or information to support the business.
• Ensure compliance with local regulations and corporate policies and procedures.
• Acquire and expand knowledge in local regulations related to regulatory affairs.
• Where applicable, may be involved in other regulatory projects from local, regional and/or Global Regulatory Affairs from time to time with close and direct supervision from RA Manager

WHO YOU ARE :

• Graduate of Bachelor of Science in Pharmacy or Industrial Pharmacy
• Preferably passed the Professional Pharmacy Licensure Examination
• At least 1-year experience in Regulatory Affairs.
• Working experience related to Regulatory Affairs is an advantage.
• Ability to focus on multiple issues at one time, ability to organize, prioritize and work under time pressure. Computer literate.
• Good time management skills
• Good document organization skills