Oncology Regulatory Affairs Specialist (CDMO)

BSP Pharmaceuticals S.p.A.; Latina; On-site; EUR 35,000 - 40,000; Full time

Job summary

BSP Pharmaceuticals S.p.A. in Italy is seeking a Regulatory Affairs Specialist to support regulatory compliance, GMP documentation control, and the preparation of dossiers for registrations and post-registration activities, including international filings.

The ideal candidate has a science degree (Chemistry, Pharmacy or Biology) and at least 3 years of regulatory experience in complex organizations, with GMP knowledge and working English.

Qualifications

• A minimum of 3 years in regulatory roles within the pharmaceutical industry.
• Knowledge of GMP and quality systems.
• Working knowledge of English in a professional setting.
• Proactive, can-do attitude and ability to manage multiple tasks.

Responsibilities

• Support regulatory compliance monitoring through GMP documentation control.
• Manage regulatory document storage databases.
• Assist in dossiers preparation for registrations and post-registration steps (including eCTD).
• Coordinate consular paperwork for international registrations with external entities.
• Support MIA maintenance and variations/registrations for import of active substances.

Skills

GMP knowledge

English proficiency

Regulatory affairs experience

Can-do attitude

Education

Bachelor's in Chemistry/Pharmacy/Biology

Master's in Regulatory Affairs

Job description

BSP Pharmaceuticals S.p.A. in Italy is seeking a Regulatory Affairs Specialist to support regulatory compliance, GMP documentation control, and the preparation of dossiers for registrations and post-registration activities, including international filings.

The ideal candidate has a science degree (Chemistry, Pharmacy or Biology) and at least 3 years of regulatory experience in complex organizations, with GMP knowledge and working English.