Onsite Regulatory Affairs Consultant — CTD Module 3 Expert

Amaris Consulting | Part of Mantu; Latina; On-site; EUR 26,000 - 50,000; Full time

Benefits offered by this job

International community

Internal Academy training

Team events and activities

Well-being and work-life balance

Job summary

Amaris Consulting | Part of Mantu is seeking a Regulatory Affairs Consultant for a fully onsite position in Latina, Italy. You will draft and review CTD Module 3 quality sections, prepare documentation for new marketing authorisations and support clients through registrations and responses to deficiency letters.

You should have a degree in a relevant scientific field and prior regulatory affairs experience focusing on CMC and CTD Module 3, with strong English (and Italian at least C2).

Qualifications

• Experience in pharmaceutical Regulatory Affairs with focus on CMC documentation and CTD Module 3.
• Knowledge of CTD structure, especially Module 3 and the Quality section.
• English written and spoken; Italian native or C2 level.

Responsibilities

• Draft and review Quality and CMC sections of regulatory dossiers, focusing on Module 3 of the CTD.
• Prepare and update pharmaceutical quality documentation for new marketing authorisation applications.
• Provide regulatory support to clients during new registration processes.
• Assist in preparing responses to Deficiency Letters from regulatory authorities.
• Review manufacturing, control and validation data included in regulatory submissions.
• Assess documentation related to sterile pharmaceutical manufacturing processes.
• Collaborate with clients, manufacturing sites, Quality teams and regulatory stakeholders.
• Contribute to clear, accurate regulatory responses.

Skills

Regulatory Affairs

CTD Module 3

CMC documentation

English proficiency

Italian language (native or C2)

Education

Degree in Pharmaceutical Chemistry and Technology, Pharmacy, Chemistry, Biotechnology or related field

Job description

Amaris Consulting | Part of Mantu is seeking a Regulatory Affairs Consultant for a fully onsite position in Latina, Italy. You will draft and review CTD Module 3 quality sections, prepare documentation for new marketing authorisations and support clients through registrations and responses to deficiency letters.

You should have a degree in a relevant scientific field and prior regulatory affairs experience focusing on CMC and CTD Module 3, with strong English (and Italian at least C2).