Senior CMC Regulatory Specialist | Global Pharma

Zambon; Bresso; On-site; EUR 50,000 - 70,000; Full time

Job summary

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.

Qualifications

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

Responsibilities

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

Skills

Regulatory Affairs/CMC experience

Knowledge of cGMP, ICH and FDA regulations

Excellent English proficiency

Education

Degree in Life Sciences/Health Related Sciences

Job description

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.