By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. **Job Description** **ROLE OBJECTIVE** Align with expected objectives skills and competencies: + Act as a local responsible person for RA + Lead and secure local regulatory activities + Prepare documentation for and drive local regulatory submission processes + Ensure 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 products + Ensure 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 preparation + Prepare/manage translations for SmPC, PIL and product labelling and manage their distribution to key stakeholders within the company + Translation of DHPC letter to local language and HA notification + Artworks management + Review content of local aRMM materials and provide comments, if necessary + Establish and enhance relationships/communication with regulatory authorities + Ensure 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 reports + Proper archiving of the regulatory documentation + Prepare local Procedures relevant for Regulatory affairs and provides regulatory input to other areas e.g. SOPs + Review promo-materials from regulatory point of view if required + Notify and keep the records of the Medical Devices according to local requirements + Comply with companies Compliance Policies and Quality standards **Experience and Education** + University Degree – preferably in Medicine, Pharmacy, Veterinary, Chemistry or Nature Sciencies + Advanced knowledge of local regulatory requirements + In-depth knowledge of applicable regulatory affairs laws, regulations and policies, both national and international + At least 1 year of experience in Regulatory in Pharmaceutical Industry + Knowledge of Medicinal Product development process + Knowledge of storage and distribution process of Medical Devices + Fluent English, able to attend and discuss presentation of projects. + Experience in project management + Articulate, positive, work ethic, confident, enthusiastic, flexible, team player. + Good interaction with and influencing of others, both internally and externally + Ability to handle multiple tasks and good prioritizing ability **Locations** Bratislava, Slovakia **Worker Type** Employee **Worker Sub-Type** Regular **Time Type** Full time