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Senior Regulatory Affairs Associate (Czech Republic, Prague)

Parexel International Corporation

Prague, Hlavní město Praha, Czechia

Senior Regulatory Affairs Associate

- acting as a local regulatory contact representing various MAH's in Slovakia and/or Czech Republic, esp. covering all MA's related maintenance activities

- acting as a local regulatory contact for clinical trials in the Czech Republic, Slovakia and Canada

• Preparation and quality control of core regulatory submission packages, preparation and quality control of local regulatory submission packages for submissions to RA's in the Czech Republic, Slovakia and Canada to ensure regulatory compliance, accuracy and completeness. Providing regulatory consultancy and support for establishing the submission strategy for clinical trial application, response management, amendments and other maintenance submissions.

• Interacting with Czech, Slovak and Canadian regulatory authorities, as required; liaise with internal and external partners on assigned projects, provide internal and external regulatory consultancy.

• Preparation, review and approval of labels. Later when he/she get more experience/familiar with our processes to act as RL or RAL coordinating the CTA and/or MAA.

• Global Regulatory Lead for clinical trial applications coordinating regulatory activities on international multi-center trials (design, plan and schedule activities and deliverables; interact with client and project team), support and development of submission plans and strategy to regulatory authorities, oversight and support for response management. And mentor junior colleagues and performing trainings and support for submissions in the 3 countries.QualificationsIdeally, the candidate should be Czech or Slovak native with university education in the natural sciences (biochemistry, biotechnology, pharmacist) and at least 2 years experience in the regulatory affairs area - CTA and/or MAA.

Job posted: 2021-09-14

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