GENEL NİTELİKLER VE İŞ TANIMI
We are seeking a "Temporary Regulatory Specialist" with the following qualifications for our multinational client which is operating in the pharmacy sector.
· Ensures timely submission and follow-up of both labeling and quality-related variations to the marketing authorizations and GMP related submissions, in cooperation with the key stakeholders: Worldwide Product Labeling, MMD, iCMC, EEMEA Regulatory Affairs and Regulatory Affairs.,
· Manages the renewal process in liaison with the HQs, ensuring that the renewal files are prepared, submitted and approved in due time,
· Ensures timely and proper submissions for license transfers of related products Handles the control of packaging components artworks developed by labeling coordinator,
· Works in close collaboration with Labeling Coordinator for the artworks’ approval process and the follow-up of the printing process to ensure proper implementation of artworks changes,
· Coordination and close follow-up with local partners.
· Degree of Pharmacy, Chemistry, Chemical Engineering, Biology or equivalent,
· Minimum 2 years of experience in Regulatory Affairs in similar position,
· Leadership competencies,
· Strategic thinking and proactive management capability,
· Collaboration and active communication,
· High sense of customer orientation,
· High sense of collaboration,
· Advanced negotiation skills.
Manpower, Türkiye İş Kurumu’ndan 18.8.2016 tarihli ve 6 no’lu Özel İstihdam Bürosu izin belgesi ve 3.6.2017 tarihli Geçici İş İlişkisi Yetki Belgesi sahibidir. İş arayanlardan hiçbir ad altında menfaat temin edilmez ve ücret alınmaz.