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www.cvonline.hu

Regulatory Affairs Manager


  • A hirdetés 636 napja lejárt

 

 

Regulatory Affairs Manager

 

JOB PURPOSE:

Manages all regulatory activities required for registering the company’s new products including (Pharmaceutical products, Cosmeceuticals, food supplements, health/general sale products) within the local market and other export markets. Maintains the marketing authorizations of the products.

 

KEY ACCOUNT ABILITIES:

  • Assures that current and future local/ regional/ global Regulatory Affairs objectives in alignment with commercial objectives effectively.
  • Coordination, management and overseeing of all the regulatory activities including registration, modification and renewal of Marketing Authorizations through European procedures.
  • Compilation and management of the new registration files for nationally register the company products.
  • Submits the registration files on time.
  • Ensures that the company strictly follows government/ regional rules and regulations.
  • Supports the development and implementation of regulatory strategies and leads efforts to obtain and maintain regulatory approvals.
  • Provides creative and innovative solutions to address difficult regulatory issues.
  • Manages the preparation and filing of regulatory documentation to ensure accurate submission within strict timeframes.
  • Liaison with the regulatory authorities in Europe.
  • Liaison and day-to-day contact with the National Institute of Pharmacy in Hungary.
  • Oversees documentation efforts to ensure compliance with domestic, regional and international regulations and standards.
  • Communicates regulatory information to multiple departments and ensures that information is interpreted correctly.
  • Manages a team of Regulatory Affairs staff, giving them the needed support to achieve company goals and objectives.


QUALIFICATIONS (EDUCATION AND WORK EXPERIENCE):

  • B.Sc. in Pharmaceutical Sciences preferably a higher post-graduate degree.
  • A minimum of 10 years of experience in pharma regulatory
  • Proficiency in using eCTD format.
  • Good command of English language written and spoken.
  • Proficiency in MS Office: Word, Excel, PowerPoint.


Please send your detailed CV to the following e-mail address: E-mail cím megjelenítése

Helyek Budapest
Pest
Kategória Tudomány / Kutatás, fejlesztés
Szervezés / Menedzsment / Cégvezetés
Gyógyszeripar / Vegyipar
Minimális tapasztalat Több mint 5 év
Szükséges iskolai végzettség Egyetemi végzettség
Munkaidő tipusa Teljes munkaidő
Elvárt nyelvtudás Angol
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