Regulatory Affairs Pharmacist

Company Description

Medinova Pharmaceutical Incorporated was established in 2016 with a mission to provide affordable healthcare products to the Philippines without compromising on quality. We import, register, and distribute a wide array of foreign pharmaceutical products, including Cardio, Oncology, Anti-Infectives, Neuro, Gastro, Optha, and Urology products. With partnerships with 98 manufacturers from 7 countries, we strive to make quality healthcare accessible to all Filipinos.

Role Description

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.

Qualifications

• Must be a graduate of BS Pharmacy and a licensed Pharmacist. Fresh graduates are preferred.
• Must show evidence of leadership and achievement in past academic or professional careers.
• Must have a growth mindset.
• Must have the ability to collaborate effectively.
• Excellent in verbal and written communication skills.
• Must be well versed in using Microsoft Office applications.