Regulatory Affairs Manager (f/m)


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Kontakt: Alexandra Lange
Email: Nicht verfügbar
Telefon: +43 1 5037244-942

AOP Orphan Pharmaceuticals AG is a European pioneer with focus on rare diseases. We develop and market innovative solutions beyond drugs.To enhance our team in Vienna we are looking for a:

Regulatory Affairs Manager (f/m)

As part of our Regulatory Affairs team you will play a key role in the management of new regulatory projects and existing approvals.

Ready for an ambitious job?

  • You are tracking current legislation and guidelines to support global regulatory submissions according to country specific requirements
  • You support the preparation of eCTD applications via DocuBridge and perform eSubmissions according to current requirements
  • You are responsible for regulatory data management and electronical xEVMPD (IDMP) reporting
  • You manage and improve internal change control processes and SOP’s
  • You are responsible for defined products from a regulatory perspective

Able to align?

  • You enjoy working in a high-performing international environment
  • You provide regulatory know-how to Project Teams involved with the development of new products
  • You are a team player and like to work cross-functional and with external partners

Looking for an agile environment?

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

Professional skills

  • University degree in Natural Science
  • 3-5-year Regulatory Affairs experience in the pharmaceutical industry
  • In-depth knowledge of international regulatory requirements
  • Profound software skills (MS office, eCTD software and regulatory databases)
  • Attention to detail and demonstrates the ability to prioritize
  • Fluent in English and German

The gross monthly salary provided for this function is a minimum of € 3.000, - based on full-time employment. Any potential overpayment depends on professional experience and qualifications.

If you like this AOPPORTUNITY please send your application to:

Angelika Drabek

AOP Orphan Pharmaceuticals AG

Wilhelminenstraße 91/II f, 1160 Wien

Tel.: 01/503 72 44-62, Fax: 01/503 72 44-61

e-mail: recruitment@aoporphan.com

 

 

 


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