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Job Description

ROLE OBJECTIVE

Align with expected objectives skills and competencies:

Act as a local responsible person for RALead and secure local regulatory activitiesPrepare documentation for and drive local regulatory submission processesEnsure proper management of registered drugs with regards to regulatory maintenance activities

ACCOUNTABILITIES

Leadership

Represent RA at departmental meetings and closely co-operate with other functions (PV, QA, Market Access, Sales, Marketing and Medical Affairs)

Regulatory Affairs Manager:

Lead and secure local regulatory activities: new product authorizations, variations and renewals for all already authorized productsEnsure that Takeda meets the regulatory requirements of the relevant authorities (including also but not limited to RMPs, blue-box-requirements, PSUR submission, etc).Prepare documentation and drive local regulatory submission processes (new applications, variations, notifications, renewals, transfers, etc) in alignment with launch strategy & launch plan and ensure timely and adequate regulatory submission/approval.Prepare documents for eCTD creation and manage eCTD preparationPrepare/manage translations for SmPC, PIL and product labelling and manage their distribution to key stakeholders within the companyTranslation of DHPC letter to local language and HA notificationArtworks managementReview content of local aRMM materials and provide comments, if necessaryEstablish and enhance relationships/communication with regulatory authoritiesEnsure that Takeda corporate standards are in alignment with local regulatory affairs and respond adequately to the functional leads at Headquarters.Keep update knowledge about Regulatory regulation and procedures.Keep record of Regulatory activity and updates required files and databases and prepares reportsProper archiving of the regulatory documentationPrepare local Procedures relevant for Regulatory affairs and provides regulatory input to other areas e.g. SOPsReview promo-materials from regulatory point of view if requiredNotify and keep the records of the Medical Devices according to local requirementsComply with companies Compliance Policies and Quality standards

Experience and Education

University Degree – preferably in Medicine, Pharmacy, Veterinary, Chemistry or Nature ScienciesAdvanced knowledge of local regulatory requirementsIn-depth knowledge of applicable regulatory affairs laws, regulations and policies, both national and internationalAt least 1 year of experience in Regulatory in Pharmaceutical IndustryKnowledge of Medicinal Product development processKnowledge of storage and distribution process of Medical DevicesFluent English, able to attend and discuss presentation of projects.Experience in project managementArticulate, positive, work ethic, confident, enthusiastic, flexible, team player.Good interaction with and influencing of others, both internally and externallyAbility to handle multiple tasks and good prioritizing ability

LocationsBratislava, Slovakia

Worker TypeEmployee

Worker Sub-TypeRegular

Time TypeFull time