REGULATORY AFFAIRS ASSOCIATE

It is the spirit of Bayanihan that drives us to continue our legacy of excellence and commitment to care. As an organization, we achieve our successes through good, honest, and persevering hard work - TOGETHER. It is in this way in which our company was built; we progressed as the country's leading Pharmaceutical company, not by sheer luck, but by pure perseverance, integrity, and brotherhood. Grow with us, and be a part of the Bayanihan spirit.

Role Overview

• Communicates registration requirements to Enablers
• Handles Food and Drug Administration's registration documents                                 
  • Refers to the checklist needed to comply for submission                              
  • Evaluates and assesses the completeness and correctness of documents
  • Puts together validated Registration requirements
  • Submits and monitors status updates of submitted documents
• Manages product registration and renewal of existing products
• Files Amendments/Variations with the Food and Drug Administration
• Prepares monthly operations reports and other assigned tasks

Required Qualifications

• Graduate of Bachelor of Science in Pharmacy, and must be a licensed pharmacist
• With 1-2 years experience in Regulatory and/or Medical Affairs
• Knowledgeable in FDA guidelines and medical information
• Must have good interpersonal skills and able to work well independently
• Attention to detail, ability to multi-task and meet strict deadlines

We are committed to providing our employees with the best possible experience. As a LEARNING ORGANIZATION, we are eager to support your development and create the most fitting career path for you. As DESIGNERS AND DRIVERS OF INNOVATION, we are keen to provide you with opportunities to positively transform processes that will intensify business growth. As a NURTURING FAMILY, we are passionate about conducting programs that can promote your wellness, and help you be the best that you can be. As BELIEVERS OF OUR PURPOSE, we are and we will always remain earnest in giving meaningful tasks that will keep you delighted and fulfilled - at work and beyond.