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Animal Health Regulatory Affairs Executive

İstanbul Avrupa Yakası, İstanbul Anadolu Yakası
  • 20.11.2020
  • 0 - 50
  • 1414 Görüntüleme

Job Description

The selected candidate will be hired as an outsource.

The individual will be responsible for preparing the GMP and Registration files, to file the applications and to maintain the products life cycle process. He/She will be reporting to Head of Regulatory Affairs & Pharmacovigilance Turkey. The position is under Regulatory Affairs & Pharmacovigilance function in our Animal Health Business Unit.

  • To prepare the registration application files, to submit applications and to follow up the registration process,
  • To prepare the GMP application files, to submit applications and to follow up the process,
  • To prepare, submit and follow up variation applications,
  • To follow up technical questions from Ministry of Health, Boehringer Ingelheim Corporate and Boehringer Ingelheim Turkey,
  • To make preparations for renewals of registered products,
  • To maintain product registrations and Regulatory Affairs databases,
  • To proceed packaging studies,
  • To ensure the control of the Certificates of Analysis for each batch of imported/ locally manufactured products for compliance purposes,
  • To collaborate cross-functionally and make sure that all relevant stakeholders are timely and pro-actively updated on relevant RA topics,

Required Skills

  • Pharma experience with regulatory focus in a multinational for at least 2 years,
  • Knowledge of regulations in regulatory environment (locally and globally),
  • Minimum bachelor’s degree in Veterinary Medicine, Chemistry, Pharmaceutics and/or Biology,
  • Good command of MS Office (Word, Excel and PowerPoint) skills,
  • Fluency in English and Turkish,
  • Advanced communication skills,
  • Planning and organization skills,
  • Customer orientation,
  • Cooperation and team work,
  • Analytical and strategical thinking,
  • Result oriented,

Summary Info

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