Regulatory Affairs Associate

Want to know more?

INSUD PHARMA operates across the entire pharmaceutical value chain, providing specialized knowledge and experience in scientific research, development, manufacturing, sales, and marketing of a wide range of active pharmaceutical ingredients (API), finished dosage forms (FDF), and branded pharmaceutical products, adding value to human and animal health.

The activities of INSUD PHARMA are organized into three synergistic business areas : Industrial (Chemo), Branded (Exeltis), and Biotech (mAbxience), with over 9,000 professionals in more than 50 countries, 20 state-of-the-art facilities, 15 specialized R&D centers, 12 commercial offices, and more than 35 pharmaceutical subsidiaries, serving 1,150 customers in 96 countries worldwide. INSUD PHARMA believes in innovation and sustainable development.

Ready to be a #Challenger?

What are we looking for?

We are incorporating a new INSUDER as Regulatory Affairs Associate at our plant in León.

The Challenge!

• Understand the needs of each customers and project and align them with the strategic guidelines of Chemo.
• To stay updated on changes in legislation and regulations and advises and gives interpretation on the potential impact to the product registration, marketing, manufacturing or development.
• To advice R&D team on Regulatory requirements for registration dossier.
• Compilation of required information for registration dossiers and for notifications (pharmaceutical products, food supplements and cosmetics)
• Registration submission and follow up with Health Authorities and Licensees, until product approval and launch.
• Coordinate the submission and the approval for the Free Sales Certificates.
• Coordination and preparation of Answers to deficiencies letters received from Health Authorities.
• Maintains regulatory files / database and chronologies in good order. Establish and maintain system for tracking changes in documents submitted to agencies or licensees.
• Reviews product labelling for compliance with regulatory requirements.
• Review and advice on product changes for impact on regulatory filings worldwide.
• Technical support to the sales department with the technical requirements of the customers.
• Serves as regulatory liaison throughout product lifecycle.

What do you need?

Our benefits!

Attractive salary package.

Permanent Contract. Full time from Monday to Friday