Team Lead Global Regulatory Affairs Strategy(m/w/x)

Team Lead Global Regulatory Affairs Strategy (f/m/d) ==================================================== | 1190 Wien | Vollzeit | Start: as of now | **In this role, you will lead a regulatory affairs team and oversee strategy, submissions, and compliance for assigned products. Combining team leadership with hands-on regulatory expertise, you’ll ensure timely, high-quality submissions and effective lifecycle management across key therapeutic areas.** What Your Day To Day Will Look Like * Manage, support, and develop direct reports within the regulatory team, setting objectives and evaluating performance. * Act as regulatory lead for assigned products, coordinating submissions and ensuring compliance with EU and non-EU regulatory frameworks. * Supervise the preparation and maintenance of marketing authorization dossiers in collaboration with R&D and internal stakeholders. * Lead the lifecycle management of authorized products, including handling deficiency letters and change requests. * Drive regulatory planning and ensure alignment with internal and external timelines and expectations. * Maintain oversight of the regulatory quality management system (SOPs, work instructions, and departmental processes). * Coordinate with internal departments and external partners (e.g., RA consultants) on submission-related matters. * Oversee regulatory budget planning, invoice tracking, and consultancy fee processing. * Stay updated through continuous training and participation in external regulatory events. * Act as the administrator for Lorenz DocuBridge software for document and submission management. Your **Qualifications and Experience** * University degree in natural sciences or equivalent. * Minimum 5 years of regulatory experience with solid knowledge of EU regulatory frameworks and lifecycle management. * Proven ability or potential to lead a small team with strong organizational and decision-making skills. * Experience coordinating regulatory submissions and communicating with authorities. * Strong sense of responsibility, attention to detail, and ability to work independently. * Skilled in working cross-functionally and managing both internal and external stakeholders. * Excellent written and spoken English communication skills. Our Offer * A position with personal responsibility and space for creativity * Open corporate culture with the opportunity to bring in your own ideas * Highly motivated, agile, and international team * Great opportunities for personal and professional development * Attractive work environment with excellent career opportunities and flat hierarchies * Competitive salary package plus bonus, various benefits * Gross annual salary for this function is a minimum of EUR 90.000.- based on full-time employment (38.5 hours/week). Any potential overpayment depends on professional experience and qualifications. Main Benefits * Bonus * Homeoffice * Flexible working hours * Initial and continuing education * Canteen * Employee events * Meal allowance * Company doctor * Parking spot * Healthmeasures