CMC Senior Specialist

ION; Milano; In loco; EUR 65.000 - 85.000; Tempo pieno

Descrizione del lavoro

A multinational pharmaceutical company in Milan is seeking a CMC Senior Specialist to provide technical support for product registration dossiers. The role involves managing CROs and CMC regulatory strategies, alongside writing and reviewing important protocols. The ideal candidate will hold a degree in Life Sciences, possess over 5 years of Regulatory Affairs experience, and have excellent English communication skills. This role plays a critical part in enhancing the quality of health care and patient life through innovative solutions.

Competenze

• 5+ years of experience in Regulatory Affairs/CMC preferably in Corporate Roles.

Mansioni

• Managing of the CROs/CMOs performing necessary process development.
• Managing of the CMC regulatory strategy for submission and review.
• Writing and review of protocols and reports for regulatory submissions.

Conoscenze

Excellent knowledge of written and spoken English

Regulatory Affairs expertise

Formazione

Degree in Life Sciences/Health Related Sciences

Descrizione del lavoro

Join to apply for the CMC Senior Specialist role at Zambon

Zambon is a multinational pharmaceutical and chemical company that focuses on innovation and development with the aim to improve the quality of people’s health and patients’ lives. Based on a valuable heritage but strongly focused on the future, its Vision is “Innovating cure and care to make patients’ lives better”. Zambon operates in the pharmaceutical and chemical business and is present in 20 countries with subsidiaries in three different Continents – Europe, America, and Asia – and over 2900 employees, with manufacturing units in Italy, Switzerland, France, China, and Brazil. Zambon products are commercialized in 84 countries. The company is working on the treatment of specialties and rare diseases, such as Parkinson’s disease and Cystic Fibrosis, and is well-established in 3 therapeutic areas: respiratory, pain, and women’s care.

The Role

Zambon SpA is looking for a CMC Senior Specialist that will ensure the technical support for management of product registration dossier and will write and review the Quality Part of the CTD with internal and external resources.

Main Responsibilities of the role

• Managing of the CROs/CMOs performing all the necessary process development, manufacturing and analytical activities required for all drug substance and drug product development activities in support of new dossier submission for registration and product lifecycle in collaboration with the other internal stakeholders.
• Managing of the CMC regulatory strategy for the submission and during the review phase by the Health Authorities.
• Writing and review of protocols and reports in support of regulatory section submissions (Module 3 eCTD).
• Designing plans for the validation and registration of API and DP as required by cGMP, ICH (International Conference of Harmonization) and FDA regulations.
• Writing and/or reviewing Module 3 of eCTD in collaboration with consultants as required; prepare, review CMC regulatory and Quality documents.

What we are looking for

• Degree in Life Sciences/Health Related Sciences (CTF/Pharmacy).
• 5+ years of experience in Regulatory Affairs/CMC preferably in Corporate Roles.
• Excellent knowledge of written and spoken English.