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Regulatory Affairs Specialist (Turkey)
UpworkAnkara, Ankara, Turkey2 gün önce
İş tanımıInitiates, reviews and approves new or revised product artworks in collaboration with Cluster Artwork Coordinator. Identifies & initiates local process improvement opportunities and manage changes as required Knowledge of consumer healthcare environment and product development Understanding of processes and departments within a healthcare company Effective time and organisation management Excellent communication skills, with the ability to articulate and express concepts clearly both verbally and in writing, particularly when simplifying complex regulatory or technical issues. Good interpersonal skills; able to build effective personal networks internally and externally. Collaborative with a strong sense of ownership, willing to be held accountable and be rewarded for delivering results. Strong organizational and time management skills with an ability to work under pressure. Able to work effectively in a multi-cultural, highly matrixed organization Proficiency in English
Job Description
The Roles & Responsibilities include;
Regulatory Strategy
- Prepares and submits regulatory submissions according to applicable regulatory requirements and guidelines.
- Collects and evaluates information on regulatory requirements for quality, preclinical and clinical data to meet applicable regulations.
- Monitors the progress of the regulatory authority review process through appropriate communication with the Health Authority, seeking opportunities to expedite regulatory approvals where possible.
- Develops and maintains a thorough understanding of the regulatory environment and supporting data requirements
Regulatory Compliance
Qualifications
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Turkey • Ankara, Ankara, Turkey