Country: Austria
City: Brunn am Gebirge
Department: Research & Development
Job ID: 43478
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If you’re passionate about changing lives for the better, this is the opportunity you’ve been waiting for. In Research & Development, we’re continuously exploring innovative new treatment options to make a stronger, more positive impact on the lives of the patients we serve. You’ll work with talented colleagues in a state-of-the-art Research & Development environment, developing innovative medicines that change the live of patients for the better and help us make progress towards our vision of a world free of pain. Join us today, and discover the difference you can make.
What the job looks like
o Ensure local regulatory approval and maintenance of product licenses.
o Support and ensure timely submission of applications for CTAs, MAs, variations and renewals.
o Ensure maintenance of product information texts and the review of regulatory aspects of company product related materials.
o Maintain overview of the registration status for all products in Austria, including tracking of all submissions and commitments.
o Operational support to Drug Safety DACH Team in e.g. ICSR identification, Regulatory Intelligence monitoring, implementing risk minimization measures
o Maintain and monitor compliance infrastructure within the company to ensure compliance with local pharmaceutical industry practices, Pharmig Code and GRT Code of Conduct.
o Plan and conduct compliance trainings.
o Active participation in compliance audits and inspections.
o Ensure local regulatory approval and maintenance of product licenses.
o Support and ensure timely submission of applications for CTAs, MAs, variations and renewals.
o Ensure maintenance of product information texts and the review of regulatory aspects of company product related materials.
o Maintain overview of the registration status for all products in Austria, including tracking of all submissions and commitments.
o Operational support to Drug Safety DACH Team in e.g. ICSR identification, Regulatory Intelligence monitoring, implementing risk minimization measures
o Maintain and monitor compliance infrastructure within the company to ensure compliance with local pharmaceutical industry practices, Pharmig Code and GRT Code of Conduct.
o Plan and conduct compliance trainings.
o Active participation in compliance audits and inspections.
What you'll bring to the table
o University degree in economics or sciences and/or advanced degree in health or life sciences.
o Work experience in regulatory affairs and drug safety within the pharmaceutical industry.
o Thorough knowledge of regulatory and drug safety processes and relevant Regulations (EU legislations and guidelines, local law etc).
o Preferably knowledge in NeeS/eCTD publishing software (e.g.DocuBridge).
o Very structured and attention-to-detail working style.
o Strong communication, negotiation and problem solving skills.
o Ability to work flexible, proactive, open, adaptable to environment and supportive of training.
o Strategic thinking, commercial awareness and ability to work in a global matrix environment.
o Fluent business English language skills.
o Work experience in regulatory affairs and drug safety within the pharmaceutical industry.
o Thorough knowledge of regulatory and drug safety processes and relevant Regulations (EU legislations and guidelines, local law etc).
o Preferably knowledge in NeeS/eCTD publishing software (e.g.DocuBridge).
o Very structured and attention-to-detail working style.
o Strong communication, negotiation and problem solving skills.
o Ability to work flexible, proactive, open, adaptable to environment and supportive of training.
o Strategic thinking, commercial awareness and ability to work in a global matrix environment.
o Fluent business English language skills.
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