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Job

Quality Assurance and Regulatory Affairs Officer

  • Location

    Milan

  • Sector:

    Life Sciences

  • Job type:

    Contract

  • Contact:

    Sandeep Bains

  • Contact email:

    s.bains@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    2 months ago

  • Duration:

    12 Months FTC

  • Expiry date:

    2022-04-18

  • Startdate:

    ASAP

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 Quality Assurance and Regulatory Affairs Officer on a 12 Month FTC basis.  

The role will involve but not be limited to:

  • Support in supervising the performances of the activities 3PLs. in relation to GDP requirements and agreed services.
  • Maintain, update, and archive the local QMS documentation (e.g., procedures, records, etc.).
  • Prepare, update, and review the technical/quality agreements.
  • Timely packaging component artwork review and approval, following company processes and systems, to ensure that all relevant local legislation is met.
  • Provision of local regulatory advice and support to HQ Regulatory Affairs, cross-functional teams, affiliates, and partners, as necessary.
  • Maintain electronic records for all submissions and communications with regulatory authorities, together with any supporting documentation.
  • Support the oversight and management of, and collaboration with, the external PV vendor.
  • Liaise with Medical Affairs and Commercial to ensure awareness of all organized data collection systems being performed in Italy.

As a Senior Regulatory Affairs Manager, you will need:

  • Degree in life science or equivalent with a minimum of 2 years’ experience in Quality in the Pharmaceutical Industry.
  • Knowledge of Good Distribution Practice
  • Effectively working with cross-functional teams.
  • Good technical writing and editing skills.
  • Fluent in Italian and English - both verbal and written.

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 s.bains@hamlynwilliams.com.

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