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Our client is the Austrian affiliate of a top 20 global pharmaceutical research company. The company is committed to turning innovative science into medical solutions that bring value and hope to patients and their families.  Keeping the focus on addressing unmet medical needs and on conducting business with ethics and integrity enables the company to improve the health of people around the world. The company’s product portfolio has an excellent reputation amongst HCPs in Austria and on the global market.

Located in Vienna we are currently seeking for a

Senior Regulatory Affairs Manager (w/m/d)

Responsibilities:

  • Manage all regulatory affairs tasks including submissions to local HAs, in line with legal requirements, internal SOPs and business objectives
  • Review and approval of promotional materials
  • Execution of international RA strategies and plans on the Affiliate level
  • Manage interactions and communication with the local Health Authorities and act as the main point of contact for all related topics
  • Manage the local strategy, life cycle and compliance 
  • Maintain knowledge in respect of regulatory requirements and communicate changes in regulatory information within the organization.
  • Development and maintenance of professional relationships with external stakeholders and industry associations
  • Cooperate with functional areas of the local organization such as Medical Affairs, Commercial, Market Access, Legal, etc. and with international RA

Required skills, qualifications and experience:

  • Masters Degree in Life Sciences (e.g. Pharmacy, Biology, veterinary Medicine or equivalent discipline) and minimum 5 years of relevant experience in drug regulatory affairs
  • Excellent knowledge of pharmaceutical laws and regulations and experience in working with Regulatory Authorities
  • Good negotiating and influencing skills. Capability of managing negotiations with Regulatory Authorities
  • Excellent communication skills in German and English
  • Good planning and problem-solving skills, along with the ability to build and manage close relationships with all relevant stakeholders

Our offer:

  • The base salary for this position amounts to minimum EUR 70.000 gross p.a. depending on your experience and qualifications the salary might be higher
  • Company car also for private use
  • Direct and unlimited contract with our client
  • Performance related bonus and attractive fringe benefits
  • Teamwork-oriented corporate culture and friendly working environment
  • Dynamic environment and interesting development perspectives
  • Successful business strategy and highly innovative product pipeline
  • Workplace in one of Vienna’s most attractive and modern areas

I will be glad to receive your application documents. In case you have questions, please do not hesitate to contact me. Regards, Monika

globe personal services GmbH
Mag. Monika Kail
DC Tower – Donau City Straße 7 in 1220 Wien
T: +43(0)1 713 02 77 - 70
M: +43 676 314 92 94
E: monika.kail@globe.at