Regulatory Affairs Specialist / Manager (m/f)

21 dan do isteka
Mjesto rada:
Rok prijave:

We have partnered with one of the leading pharmaceutical companies operating in the SEE region. The company is already well established in Croatia in the Generics, CHC and Medical Devices markets. Due to renewed strategy and growth potential our client is now expanding its team in its Zagreb office.

Regulatory Affairs Specialist / Manager (m/f)

Location: Zagreb

The role:

The Regulatory Affairs Specialist/Manager is responsible for regulatory activities and medicinal product management like registrations, renewals and variation approvals in the territory of Croatia with reporting line towards Head of Regulatory. The Regulatory Affairs Specialist/Manager is accountable for products lifecycle management ensuring accuracy and consistency of the product information and the packaging materials of the medicinal products. He /she is responsible for timely reporting of the product information changes and performs necessary updates alongside he /she ensures timely safety submissions, tracking and reporting.

The Regulatory Affairs Specialist/Manager is also responsible for review and approval of the promotional materials, recording and archiving the relevant documentation for portfolio products.

The successful applicant:

Only selected candidates will be contacted.