about 1 month ago
12 Months FTC
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
I am a Quality Assurance and Regulatory Affairs market specialist working with a large variety of clients across the pharmaceutical and biotechnology industries. If this role is of interest to you, or if you’d like to explore other opportunities in the market, please feel free to reach out directly. Contact Sonny at +44 020 8164 5340 or at firstname.lastname@example.org.