Regulatory Affairs Pharmacist

2 days ago

Pasay, National Capital Region, Philippines Medinova Pharm. Inc. Full time ₱500,000 - ₱1,000,000 per year

This is a full-time on-site role. As a Regulatory Affairs Pharmacist, you will be the owner of all processes relating to registering products. Once a product has been identified by our Sales and Business Development team, this is where the Regulatory Affairs Team comes in. Your role is key as it is impossible to offer our products if they have not been duly registered in the Philippine Food and Drug Administration (PFDA). Success in this role is determined by the number of applications submitted, how many of these are released, and how many are rejected due to deficiencies from initial evaluations.

Responsibilities can include

  • Evaluation of supplier dossiers for product registrations for drug, food supplement, and medical device products. This means you are in charge of checking for the completion and compliance of the documentation provided by suppliers based on the requirements provided by the Philippine FDA.
  • Coordinate with foreign manufacturers on the deficiencies of their dossiers and ensuring that the same is provided to complete the registration process.
  • Participate in foreign conventions held in countries like Spain, Germany, Thailand, and China to identify suppliers that we can work with based on our manufacturer criteria and registration wishlist.
  • Assessment of product artworks (including the product leaflet and box) and their compliance to the PFDA requirements.
  • Register for PFDA clearances that recognize our manufacturers' plants as sites that comply with Philippine manufacturing practices.
  • Register for product variations such as the extension of shelf life, addition of pack-size, change distributors, and other variations on the product registration after its release.Renew
  • product registrations as they near expiry.
  • Apply for Certificates of Listing Identical Drug Product (CLIDP) for customers that require products under their own brands.
  • Analyze internal processes and assess how to improve these.
  • Suggest product registrations based on data.

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