For our team we are looking for a Regulatory Affairs Manager Consultant with a 5 -10 years of experience in the role:

• Production of client administrative documents and reports to be included in regulatory submissions;
• Compile, or supervise the composing of regulatory dossiers in accordance with national requirements, EU and Extra EU countries;
• Document and track regulatory submissions and regulatory authority approval;
• Document and follow up regulatory variations;
• Manage, assembling and update CTD modules;
• Gain Regulatory authority approval;
• Provide regulatory support to clients and companies;
• Collaborate with clients head-office and departments on regulatory issues;
• Collaborate with external regulatory authorities as required;
• Provide format and contents review of packaging texts, Summary of Product Characteristics, Patient Information Leaflets and labelling;
• Provide on-going support to the Regulatory Affairs Manager and to project teams to ensure regulatory concerns are planned and accounted for and the relevant data are generated to meet project objectives;
• Preparation of Standard Operating Procedures (SOPs) and Working Practice Documents (WPDs);
• Knowledge and experience of Drug Pharmacovigilance is a plus;
• Manage, assembling and updating of Medical Devices technical file in EU and Extra EU countries;
• Knowledge and experience of Medical Devices Post-Market Surveillance is a plus;
• Knowledge and experience of of cosmetic PIF preparation is a plus.

Skills:

• Bachelor’s or higher graduate degree in a science related field, or equivalent- Master in regulatory affairs is a plus;
• Common sense and lateral thinking;
• Fluent in English, both written and oral;
• Excellent operational skills including planning, organizing and ability to motivate others;
• Ability to work independently with minimal direction and to work well within cross-functional teams;
• Ability to represent the department in project teams;
• Possess collaborative relationships to facilitate the accomplishment of work goals;
• Think of innovative solutions in work situations, trying different and original ways to deal with work problems and opportunities.

RAL equal to Euro 38,000.00 gross.

Per il nostro team siamo alla ricerca di un Validation Engineer. Il candidato è in possesso di laurea (triennale o magistrale) in discipline tecniche (chimica, CTF, ingegneria) e ha maturato un’esperienza di almeno tre anni nell’ambito della qualifica e della convalida. La sede di lavoro è Milano ma si richiede disponibilità a trasferte in tutto il territorio nazionale.

Mansioni

• Redazione documentazione di qualifica e convalida;
• Supervisione test inclusi nei protocolli di qualifica e convalida;
• Revisione documentale;
• Analisi dei dati;
• Produzione di report.

Caratteristiche richieste

• Esperienza di almeno tre anni in nell’ambito della qualifica e della convalida in aziende operanti nel settore chimico farmaceutico o società di consulenza;

• Padronanza dei concetti di metrologia e calibrazione;
• Conoscenza della strumentazione di prova;
• Conoscenza delle GMP;
• Ottima conoscenza del pacchetto office (in particolare word ed excel);
• Ottima conoscenza della lingua inglese sia scritta che parlata;

Disponibilità a trasferte in tutta Italia.