Regulatory Affairs Specialist

BSP Pharmaceuticals S.p.A.; Latina; Vor Ort; EUR 35.000 - 40.000; Vollzeit

Zusammenfassung

BSP Pharmaceuticals S.p.A. in Latina, Italy, seeks a Regulatory Affairs Specialist to support site compliance, prepare regulatory dossiers, and manage documentation across GMP and import/restriction processes.

You will coordinate external consultants, handle eCTD submissions, and maintain the Site Master File while ensuring timely variations and registrations.

Qualifikationen

• MA degree (CTF/Chemistry, Pharmacy, Biology..).
• MS degree in Regulatory Affairs is considered a plus.
• 3 years of experience in similar roles in complex organizations.
• Knowledge of GMP.
• English working knowledge.

Aufgaben

• Support monitoring of regulatory compliance by managing GMP documentation.
• Implement and manage regulatory document storage databases.
• Assist in registration and post-registration dossiers (incl. eCTD).
• Coordinate consular paperwork for international registrations with external entities.
• Support MIA maintenance, variations, and site file updates.

Kenntnisse

GMP knowledge

English proficiency

Ausbildung

MA degree in Chemistry/Pharmacy/Biology

MS degree in Regulatory Affairs

Jobbeschreibung

BSP Pharmaceuticals S.p. A is focused on the development and manufacturing of anticancer drugs with high potency and cytotoxitc characteristics for the Pharmaceuticals Industry.

BSP has been at the forefront in the fight agains cancer since 2006.

Innovation is the hallmark of BSP with investments in new technologies and production methods in a high containment plant.

We are one of the most important Contract Development and Manufacturing Organization (CDMOs) for anticancer drugs.

Come for Science. Stay for Purpose.

We are currently looking for a Regulatory Affairs Specialist

Main activities :

• Support the monitoring of the site's regulatory compliance through the implementation, management and control of the necessary GMP documentation both internal and provided by clients and suppliers;
• Implement and manage regulatory document storage databases;
• Support clients in the registration and post-registration phases through the preparation of dossiers (also in eCTD format);
• Manage consular paperwork for international registrations, coordinating the various external entities (notary, public prosecutor's office, prefecture, consulates and consultants) to issue the appropriate legalized documentation;
• Support the management of the MIA maintenance practices for the medicines production, preparing the paperwork for variations, communications, authorization/registration for the import of active substances or updating the Site Master File;

Main requirements:

• MA degree (CTF/Chemistry, Pharmacy, Biology..);
• MS degree in Regulatory Affairs is considered a plus;
• 3 years of experience in similar roles in complex organizations;
• Knowledge of GMP;
• English working knowledge;

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is :

35-40k

At BSP we believe in an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential. We respect the diversity , the different backgrounds and experiences and provide equal opportunity for all.