Regulatory Affairs and Pharmacovigilance Manager

HamlynWilliams; Milano; In loco; EUR 50.000 - 70.000; Tempo pieno

Descrizione del lavoro

A global biopharmaceutical firm based in Italy is seeking a Regulatory Affairs and Pharmacovigilance Manager to oversee compliance and regulatory submissions. The ideal candidate will need to work effectively with cross-functional teams and possess strong technical writing skills, alongside regulatory knowledge and fluency in both Italian and English. This is a 12-month fixed-term contract position.

Competenze

• Strong technical writing and editing skills.
• Experience in pharmacovigilance within the pharmaceutical industry.
• Regulatory knowledge of European procedures and local laws.

Mansioni

• Review and approve packaging components artwork to meet local legislation.
• Submit national translations to authorities as required.
• Facilitate meetings with Local Competent Authority.
• Co-ordinate PV audit of the Affiliate.

Conoscenze

Cross-functional teamwork

Technical writing

Fluent in Italian and English

Knowledge of relevant laws and regulations

Knowledge of European regulatory procedures

Descrizione del lavoro

Hamlyn Williams has partnered with a rapidly expanding global biopharmaceutical company based in Italy. This global biopharmaceutical firm is currently in a major phase of growth due to its innovative and expansive pipeline and are looking for a Regulatory Affairs and Pharmacovigilance Manager on a 12 Month FTC basis.

• The role will involve but not be limited to
• Timely packaging component artwork review and approval, following KKI processes and systems, to ensure that all relevant local legislation is met, e.g. ‘blue box’ requirements
• Submission of national translations to the authorities (if applicable, in accordance with local requirements)
• Inform RA-EMEA of new, or changes in, local guidance or laws in relation to regulatory procedures and obligations and Kyowa Kirin products
• Facilitate meetings to be held with the Local Competent Authority
• Co-ordinate the PV audit of the Affiliate, including CAPA management, in collaboration with QA and KK PV Compliance as appropriate
• Collaborate with QA in preparation and performance of audits of local vendors / contractors or partners
• Ensure all appropriate local procedures and systems are in place for the local PV system. and are managed appropriately
• As a Senior Regulatory Affairs Manager, you will need
• Effectively working with cross-functional teams.
• Good technical writing and editing skills.
• Fluent in Italian and English - both verbal and written.
• Knowledge of relevant laws and regulations in the territory
• Regulatory knowledge of European regulatory procedures and local procedures in the countries of responsibility
• Relevant experience of PV within the pharmaceutical industry
• Knowledge of regulatory compliance and change control

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