GMP Coordinator & RA Specialist

326883BR
Sep 07, 2021
Turkey

Job Description

Job Purpose:
-Contributes and support the development of submission of product registration, progress reports, supplements, amendments, and/or periodic experience reports. Supports all registration activities of the Department to ensure compliance with the requisites of the local pharmaceutical regulatory environment.

Major Accountabilities:

-To set registration plan, to perform product registration in accordance with registration and launch plan, and maintain product license with local regulation and global compliance strategy
-Review new projects and set development plan (timeline etc.) in collaboration with Global DRA and related CPO functions (Marketing, HE&P and CD&MA etc.)
-Achieve the best product registration with commercially attractive labelling in accordance with registration plan -Maintain and secure product license in terms of CMC/CDS/safety update according to local regulations/law/guidelines, company strategy and global compliance
-Ensure compliance with NP4, KRPIA code of conduct, relevant regulations and laws for related CPO activities (DRAGON update, RMP, packing materials, promotional materials/activities, PMS/drug safety reporting etc.)
-Foster and maintain good relations with internal and external stakeholders

KPIs:
-Project & stakeholder feedback
-Product license update in terms of CMC in agreed timeline
-Adherence to Novartis policy and guidelines

Minimum Requirements

Global Drug Development
REG AFFAIRS GDD
Turkey
İstanbul
Research & Development
Full Time
Regular
No
326883BR

GMP Coordinator & RA Specialist

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