Regulatory Affairs Manager (f/m)

Vienna based


Mehr Jobs von AOP Orphan Pharmaceuticals AG
Kontakt: Angelika Drabek
Email: recruitment@aoporphan.com
Telefon: +43 1 5037244-62

AOP Orphan specializes in the research of rare disorders. It develops, produces and markets innovative solutions designed to combat them, making it the European pioneer in the field of orphan diseases. The Vienna-based company is dedicated to developing personalized treatments for sufferers of rare conditions. To enhance our team in our Headquarters in Vienna we are looking for a

Regulatory Affairs Manager (f/m)

Your key responsibilities are:

  • Monitoring and coordination of EU and non EU regulatory projects
  • Responsible for Life Cycle Management of existing approvals and submission of new regulatory projects
  • Act as regulatory contact person for authorities, external partners and in-house functions
  • Provide regulatory guidance and strategy for new products
  • Compiling regulatory documents (including dossiers for submission, life cycle management and documentation)
  • Support Project Teams  involved with the development of new products
  • Implementing and maintaining a state-of-the-art filing of regulatory documentation
  • Staying up to date with new legislation

Your profile to be successful:

  • Graduate degree in Natural Science
  • 5 years Regulatory Affairs experience in the pharmaceutical industry
  • In-depth knowledge of international regulatory requirements
  • Ability to strategically plan and manage multiple projects
  • Attention to detail and demonstrates the ability to prioritize
  • Good interpersonal and communication skills
  • Proficient with MS Office (experience with DocuBridge preferred)
  • Excellent verbal and written communication skills in English and German

Our offer:

  • A versatile job with a high degree of independence and responsibility
  • Strong entrepreneurial spirit in an innovative company
  • An attractive compensation package including bonus and benefits - gross salary provided for this function is € 3.000 per month, based on full-time employment, overpayment will be dependent on professional experience and qualification

 

If you think you are the right candidate and are interested in this challenging job in a professional team, 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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