regulatory affairs strategy product specialist (f/m) in Wien

tünde simic, ma, randstad austria
jetzt bewerben

job details

Sonstige Berufe
tünde simic, ma, randstad austria
+43120100 2472023
jetzt bewerben


To further strengthen and extend the local team of our client Takeda, we are looking for a

Regulatory Affairs Strategy Product Specialist (f/m)


  • Accountable for defining the EU regulatory strategy for assigned products (maintaining and extending Shire product registrations in EU markets). Collaborates closely with all other key GRA stakeholders (including but not limited to, labeling, CMC, regulatory operations, international regulatory team and regulatory staff in the EU LOCs) to ensure that all aspects of the regional strategy is coordinated and considered.
  • Under direction of EU Regulatory Strategy Team Lead, designs EU regulatory strategies in close collaboration with GRL to obtain, maintain and extend Shire product registrations in Europe.
  • Provides regional regulatory expertise and works in close collaboration with the GRL in organizing and providing support to meetings with European Health Authorities.
  • Remains knowledgeable about current regulations and guidance, interprets and notifies appropriate personnel and remains in compliance with all current Shire trainings and internal processes,
  • Provides support to GXP inspection activities as required.
  • Ensures all regulatory documentation is stored within Shire svstems / databases in accordance with Shire standards
  • Communication and collaboration with the EU LOC team to ensure all parties are informed of all activities directly affected


  • Life sciences degree preferred.
  • Minimum of 2 - 3 years' experience in drug/biologics development the EU pharmaceutical and biotechnology industry or Government Health Agency,
  • Knowledge of EU regulatory requirements and ability to use precedent and previous experience to develop creative approaches to achieving commercial goals.
  • Ability to challenge self and others to overcome barriers and deliver high quality solutions to the business.
  • Knowledge of the drug development process and laws and regulations affecting pharmaceutical development in EU region..
  • Must be able to work in a fast paced environment with demonstrated ability to juggle multiple competing tasks and demands.
  • Excellent interpersonal, communication, analytical, and organizational skills.
  • Ability to work independently to propose solutions to complex problems, taking into consideration external factors (e.g commercial implications etc) that would be impacted by the decision.
  • Working in a matrix structure and with cross functional teams, requiring strong negotiation and influencing skills.

The minimum salary for this position is € 3.163,33gross per month (full-time); increased payment is possible. The contract will be limited until June 2019, an extension of the contract is possible.

We are looking forward to your application!

Wir weisen Sie darauf hin, dass Ihre Bewerbungsunterlagen vollinhaltlich samt aller enthaltenen personenbezogenen Daten an die Fa. Takeda zum Zwecke der Durchführung des Bewerbungsverfahrens und der Auswahl und Selektion weitergeleitet werden.

Regulatory Affairs, Pharma