Tech Stack

Description

In this role, you will lead pharmaceutical operations, ensure regulatory compliance with French and EU laws, and oversee quality systems for RAS-targeted oncology therapies. You'll interact with health authorities, manage pharmacovigilance, and collaborate across departments to support drug development and market access.

Requirements

• Licensed pharmacist in France with eligibility for Responsible Pharmacist designation.
• Deep knowledge of French Public Health Code, ANSM requirements, and EU pharmaceutical regulations.
• Experience in oncology drug development and manufacturing oversight.
• Strong leadership and cross-functional collaboration skills.
• Ability to manage pharmacovigilance and safety reporting obligations.

Responsibilities

• Organize and supervise all pharmaceutical operations (manufacturing, advertising, pharmacovigilance, batch monitoring, distribution, import/export, storage).
• Acknowledge and handle marketing authorization application files and related regulatory submissions.
• Oversee delegate and deputy pharmacists, including hiring and training.
• Implement quality system in compliance with GxP standards and French regulations.
• Participate in management deliberations affecting pharmaceutical responsibilities.