Beschreibung

You assist in preparing and submitting product registrations while ensuring compliance with regulatory standards. Your role includes reviewing documentation and coordinating with various teams to ensure high-quality submissions.

Anforderungen

• •Bachelor’s degree in scientific discipline
• •Minimum of 4–5 years of experience
• •Solid understanding of pharmaceutical legislation
• •Proven experience with EU registration procedures
• •Previous experience with non-EU registrations is an advantage
• •Strong organizational and planning skills
• •Ability to interpret and communicate regulatory requirements
• •Proactive, detail-oriented, and capable of working independently
• •Strong interpersonal and team collaboration skills
• •Proficient written and verbal communication skills in English
• •Bilingual English and French
• •High attention to detail and commitment to quality

Aufgaben

• •Support preparation and submission of product registrations.
• •Review regulatory documentation for marketing authorization applications.
• •Coordinate with internal teams and local partners for submissions.
• •Ensure compliance by comparing manufacturing details with regulatory filings.
• •Evaluate Change Controls and CAPAs' impact on MAAs.
• •Maintain registration documentation per regulatory guidelines.