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REGULATORY AFFAIRS SPECIALIST

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    Jobs › Istanbul Jobs › REGULATORY AFFAIRS SPECIALIST Jobs in Istanbul

Tarihinde güncellendi 29/04/2024

  • A Global Company in Healthcare Sector
  • Great Opportunity for Regulatory Professionals

    • Müşterimiz Hakkında

    Our client is one of the leading Global Pharmaceuticals companies.

    For their future development plans, we are looking for a:

    REGULATORY AFFAIRS SPECIALIST

    İş Tanımı

  • Fulfilling all regulatory requirements for products,
  • Prepare and submit applications for product variations, renewals, labeling updates, notifications, packagings/ labels, SPCs and PILs according to all legal requirements and regulations
  • Coordinate all activities related to MoH deficiency letters and prepare responses properly
  • Follow up the submissions in authority strictly to achieve the targeted regulator approvals
  • Prepare and submit GMP inspection dossier and follow-up till GMP certificate have been issued
  • Perform technical correspondences with licensee companies about product submissions/updates
  • Keep the regulatory compliance of the marketed products with the registered specifications defined into the dossiers
  • Follow-up recent developments and changes in the local & global regulatory environment
  • Support to product release in coordination with QA specialist
  • Archiving all correspondence and documents related to the products.

    • Aradığımız Profil

  • University degree from preferably in Pharmacy, Chemistry, Chemical Engineering or Biology
  • Analytical thinking, result-oriented, excellent follow-up & planning skills
  • Good knowledge on regulatory guidelines and procedures
  • Fluent English (written & spoken)

    • Teklif Edilenler

    Join a fast growing Healthcare Company.


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    The average salary range for REGULATORY AFFAIRS SPECIALIST in Istanbul varies, but the standard pay scale is rated A in Istanbul. Salary levels may vary depending on your industry, experience, and skills. It's essential to research and negotiate effectively.

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    The work culture at Michael Page must adhere to the as described in the Ethical framework of the UN Charter. You can gain more insights into their local workplace environment by exploring their jobs at and also by visiting their official website through .

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