drjobs Regulatory Affairs Specialist (Turkey)

Regulatory Affairs Specialist (Turkey)

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1 Vacancy
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Job Location drjobs

Ankara - Turkey

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

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

  • Initiates 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

Qualifications :

  • 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


Remote Work :

Yes


Employment Type :

Contract

Employment Type

Remote

Company Industry

About Company

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