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AOP Orphan is a European pioneer in the development, marketing and distribution of medicines for people with rare and complex diseases.To enhance our team in Vienna Headquarters we are looking for a:

Regulatory Affairs Manager (f/m/d)

Professional Skills

  • University degree in Natural Science
  • 3-5 years Regulatory Affairs experience in the pharmaceutical industry
  • In-depth knowledge of international regulatory requirements
  • Experience in Regulatory Affairs CMC
  • Ability to strategically plan, prioritise and manage multiple projects
  • Attention to details and ability to deliver high quality regulatory documentation
  • Strong communication skills to liaise with internal and external partners with different cultural backgrounds
  • Full proficiency in MS Office, knowledge of Sharepoint and an eCTD publishing tool is a plus
  • Fluent in English and German

As part of our Regulatory Affairs team you will play a key role in the submission of new regulatory projects and in the life cycle management of existing licences ((EU and non-EU scope).

Ready for an ambitious job?

  • You are responsible for the preparation and compilation of registration dossiers according to country specific requirements in collaboration with other functions.
  • You coordinate, review and proof-read responses to questions from authorities.
  • You evaluate changes for regulatory impact and filing requirements.

Able to align?

  • You act as regulatory contact person for authorities, external partners and in-house functions.
  • You provide regulatory guidance and strategy to Project Teams involved with the development of new products.
  • You offer CMC regulatory expertise for proposed changes within life cycle management and during pharmaceutical development activities.
  • You are a team player and like to work cross-functionally and with external partners.

Looking for an agile environment?

  • You prefer working with a high degree of independence and responsibility for assigned projects.
  • You have a pro-active attitude, the ability to develop new concepts and a creative approach to problem-solving.
  • You enjoy working in a growing international company introducing solutions for rare diseases to new markets.

The gross monthly salary provided for this function is a minimum of EUR 4.000.- based on full-time employment. Any potential overpayment depends on professional experience and qualifications.

Take this AOPPORTUNITY and apply now.

Your contact
Angelika Drabek
+43 1 503 72 44-62

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