Regulatory Affairs And Pharmacovigilance Manager
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
LI-SB1
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