Regulatory Affairs Manager (m/w/d)

CROMA-PHARMA is an internationally active, family-owned pharmaceutical Company with its headquarter in Leobendorf, Korneuburg district, in the north of Vienna. Many years of experience in the manufacturing of products based on hyaluronic acid and a unique level of expertise in the field of aesthetic medicine have made CROMA-PHARMA a globally renowned specialist in the dynamic and versatile business of anti-aging.
We are searching for applicants who want to make a sustainable contribution to our success as a family- run Austrian company.
We are expanding our team and therefore looking for a Regulatory Affairs Manager for Pharmaceuticals EU, UK and Switzerland.

Ihre Aufgaben

  • Life Cycle management of CTD (file and coordinate variations) in EU for DCP, UK and Switzerland
  • Ensure national compliance within DCP countries, UK, Switzerland country specific requirements (oversee and ensure notification of products in national databases, price notifications, ….)
  • Release of Labelling and Marketing Material
  • Implement Change Control Procedures if necessary during life cycle management

Ihr Profil

  • University bachelor degree is compulsory, Pharmaceutical or Biological Science
  • Experience in pharmaceutical Regulatory Affairs for pharmaceuticals DCP and Switzerland (Swiss Medics)
  • English language fluent in word and writing
  • Accurate attitude and personality who’s personality is dedicated to ensure complete documentation also under time pressure

Wir bieten

We offer a varied work in a rapidly expanding company with diverse development opportunities and company benefits, as well as flexible working hours and home office. If you want to become part of a dynamic team, we look forward to meeting you!

For this position, a salary of EUR 43,000, - (full-time, 40h) applies gross p. a. Willingness to overpayment exists and depends on the specific qualification and experience.