Regulatory Affairs Specialist

We are a global diversified pharmaceutical company looking for a Regulatory Affairs Specialist to join our team. As a Regulatory Affairs Specialist, you will be responsible for reviewing and evaluating technical, scientific, legal, and financial documentation for the registration of our products in Mexico. You will need to have a Bachelor's degree in a related field and a minimum of 2 years of experience in the area. You will be required to review and technically evaluate new registration files and modifications to registration conditions, as well as follow up on observations detected during the review of said files. You will also be responsible for preparing label projects in accordance with NOM-072 in force, NOM-137, and NOM-141, as well as gathering required documentation to respond to prevention letters issued by COFEPRIS.

Requirements

• Minimum 2 years of experience in the area
• Knowledge and experience in filing with COFEPRIS
• Bachelor's degree with a title (Chemical Pharmacist or related)
• Knowledge of applicable current regulations for the Pharmaceutical sector
• Knowledge of proceedings with COFEPRIS