REGULATORY AFFAIRS SPECIALIST

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

Regulatory

• Prepares and submits product registration dossiers to the Philippine FDA.
• Evaluates dossiers for quality and completeness.
• Prepares and submits product registration dossiers to export country affiliates/distributors.
• Maintains Licenses to Operate and Certificates of Foreign Good Manufacturing Practice with the FDA.
• Handles promotional permit applications and submits to the FDA.
• Coordinates with regulatory agencies on registrations, variations, and permits.
• Manages product information in various databases.
• Prepares and reviews procedural documents for FDA submissions and commercial orders.
• Ensures valid processes for packaging transitions.
• Provides customer support for product inquiries and transport documents.
  
  

Medical - Strategic Marketing Support

• Handles packaging artworks for product registration or promotions.
• Manages pharmacovigilance activities and reports adverse events to the FDA.
• Coordinates quality-related complaints and suspected counterfeit products.
• Supports marketing efforts with necessary documents.
  
  

Medical Education Programs

• Prepares educational materials for divisional programs.
• Implements medical training for personnel and partners.
  
  

Advertising Claims Support

• Researches and provides medical information for product claims and brand communication.
• Reviews and updates packaging text for relevant claims.
• Assists in filing complaints against competitor products.
• Coordinates product inclusion in medical directories (MIMS, PPD).
  
  

Required Qualifications

• Graduate of a Bachelor’s Degree in Pharmacy
• Must be a licensed pharmacist
• With 3 to 6 years of 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
• With keen attention to detail, and has the 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.