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Pošalji prijatelju

Regulatory Affairs Administrator (m/f)

Zagreb

Rok prijave:

Dechra is an international specialist veterinary pharmaceuticals and related products business. Our expertise is in the development, manufacture and sales and marketing of high quality products exclusively for veterinarians worldwide.

We have offices across 24 countries in Europe and North America, we export to over 50 countries worldwide and have six manufacturing sites.

Our six Dechra Values: Dedication, Enjoyment, Courage, Honesty, Relationships and Ambition reflect the best aspects of behaviour and competence in Dechra. We embrace the values at every level of the business and everything about the business is underpinned by our values. How we talk to the people that matter, the way we always look to do things better and how we think of the people and the animals beyond the product.

We are active in Companion Animal, Equine and Food Producing Animal products.

Our key focus therapeutic areas are:

  • Endocrinology
  • Dermatology
  • Anaesthesia and Analgesia
  • Water Medication
  • Diets and Nutrition
  • Equine Locomotion
And we support our clients in practice with a wide range of materials and technical advice.

Regulatory Affairs Administrator (m/f)

Job Purpose:

Regulatory Affairs Administrator is responsible for invoice coding, licenses distribution and archiving, ordering standard substances and samples for regulatory purposes, handling of legalization procedures, initiation of artwork creation process in the system etc.

RA Administrator is also updating and maintaining regulatory activities in Samarind Regulatory Information Management System (SAMI) and supporting registration procedures.

Key Responsibilities:

  • Initiate artwork creation process in TWONA and perform RA approval after finalization
  • Assist RA colleagues with overview lists, cost estimates etc.
  • Update and maintain SAMI with the support from RA colleagues
  • Ensure received invoices for RA are coded, approved and sent back to finance for payment in due course. Archive and keep an overview of paid invoices
  • Compile sales figures and reporting to Agencies as needed
  • Compiling electronic submission for new submissions, renewals and variations based on prepared dossiers for EU territories
  • Following approval of a submission ensure Marketing Authorisation is checked, that all documentation is archived according to agreed procedure and relevant documents/databases are updated. Finally ensure distribution of Marketing Authorisation information to all relevant colleagues
  • Support RA colleagues with requesting various needed certificates and samples
  • Identify risks and implement chances to ensure compliance with GMP regulatory requirements

Candidate Profile:

  • High school degree, preferably administrative
  • Experienced user of Microsoft Office programs
  • At least 2 years’ experience within administration
  • Fluent in spoken and written Croatian and English
  • Able to work in a structured way and keep an overview of various tasks and ongoing issues
  • High level of accuracy

To apply, please send us your CV and Cover letter in English via application link.

Započni prijavu
Spremi oglas Pošalji prijatelju Isprintaj

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