regulatory affairs strategy product specialist (m/w) in wien

posted
job type
festanstellung
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job details

posted
location
wien
job category
Sonstige Berufe
job type
festanstellung
working hours
Full-Time
reference number
20181004
apply now

job description

As a leading global biotechnology company our client SHIRE has one mission every day: to lastingly improve the lives of people living with rare diseases. Crucial to this mission are the employees - their biggest asset - who enjoy a range of benefits and career opportunities, such as trainee and training programs, job rotations, apprenticeships, work-life balance (certified family friendly), company kindergarten, wellness center, cafeteria, etc.

To further strengthen and extend the local team, we are looking for a

Regulatory Affairs Strategy Product Specialist (f/m)

Responsibilities:

  • 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

Requirements:

  • 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. Shire Austria GmbG zum Zwecke der Durchführung des Bewerbungsverfahrens und der Auswahl und Selektion weitergeleitet werden.

skills

Regulatory Affairs, Pharma