Senior CMC Regulatory Specialist | Global Pharma

Zambon; Bresso; In loco; EUR 50.000 - 70.000; Tempo pieno

Descrizione del lavoro

A multinational pharmaceutical company is seeking a CMC Senior Specialist in Bresso, Italy. The role involves managing regulatory submissions and ensuring compliance with cGMP and FDA standards. Candidates should have a degree in Life Sciences and over 5 years of Regulatory Affairs experience. Excellent English communication skills are essential. This full-time position offers a collaborative work environment focused on innovation and quality improvement.

Competenze

• 5+ years of experience in Regulatory Affairs/CMC.
• Strong background in preparing Module 3 eCTD submissions.

Mansioni

• Manage CROs/CMOs for drug substance and drug product development.
• Implement CMC regulatory strategy and ensure compliance.
• Write and review protocols and regulatory submissions.

Conoscenze

Regulatory Affairs/CMC experience

Knowledge of cGMP, ICH and FDA regulations

Excellent English proficiency

Formazione

Degree in Life Sciences/Health Related Sciences

Descrizione del lavoro

A multinational pharmaceutical company is seeking a CMC Senior Specialist in Bresso, Italy. The role involves managing regulatory submissions and ensuring compliance with cGMP and FDA standards. Candidates should have a degree in Life Sciences and over 5 years of Regulatory Affairs experience. Excellent English communication skills are essential. This full-time position offers a collaborative work environment focused on innovation and quality improvement.