Regulatory affairs manager

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Job Description

REGULATORY AFFAIRS MANAGER

Accountabilities

• Documentation/dossiers assessment against normative requirements, ensuring proper and timely communication on new and changed regulatory requirements to GRA and within organization

∙ Participate in development and execute regulatory plans for new drugs and maintaining licenses/authorizations for the approved ones; provide sound regulatory decisions and justifications of any proposed regulatory strategy; potential regulatory risks assessment

∙ Communicate with the global RA/manufacturers within satisfying additional requests and comments of the regulatory authorities

∙ Ensuring effective Regulatory Health Authority interactions

∙ Monitoring of applicable regulatory requirements

∙ Negotiate with State Authority’s officials; follow-ups with the authorities regarding all regulatory matters in Ukraine

∙ Perform constant checks of the product sheets, labels and regulatory tables; ensure that all documents and registrations comply with the Ukrainian regulations

• Perform registration, renewal, variation procedures, artworks development

∙ Perform GMP recognition procedures (including, request of documents, checking for compliance with the requirements of the Legislation, preparation of documents for submission, development of local documents, communication with government authorities)

∙ Collaborate with the internal stakeholders concerning the timelines of regulatory activities to insure uninterrupted supply of the products and launch of new products

∙ Develop RA SOPs

Education, Behavioural Competencies And Skills

∙ Co-operation and teamwork

∙ Ability to proactively face and solve potential or actual problems

∙ Attentive to details

∙ Good internal and external communicator

∙ Ability to deal with complexity

∙ Results oriented

∙ Sociability, systematic, attentiveness, punctuality, the ability to work under pressure and to strict deadlines

∙ Ideally have at least 2 years of experience in the same position

∙ Higher education (pharmaceutical, medical, biological)

∙ Knowledge of medicines registration legislation (Ukraine)

∙ Ability to build productive partnership with different external and internal stakeholders

∙ Fluent Ukrainian and Russian, English not lower than Intermediate

Locations

Kiev, Ukraine

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time