Manager Regulatory Data & Submission Management – Lundbeck – Veksø

Manager – Regulatory Data and Packaging Change Management Join our community of specialists and take part in the journey of restoring brain health If you have significant experience in regulatory operations, preferably data or packaging management, and have some leadership experience, this is a great opportunity to join Lundbeck’s journey as our new Manager of the Regulatory Data and Packaging Change Management Section.This is a new position created to ensure management support of two teams within the Regulatory Business Operations (RBO) department:One team is responsible for the management of data entry, to ensure accuracy and quality of key regulatory data within Lundbeck’s regulatory information management system (RIS).The other team is responsible for the processing, evaluation and approval of packaging change requests (PCRs) and artworks for Lundbeck’s pharmaceutical products globally.This position reports to the Head of Regulatory Business Operations, is based in Lundbeck’s headquarters in Valby and entails people management responsibilities for six employees as well as the coordination of few dedicated external resources.  Why should you be part of our journey? The RIS team plays a pivotal role in ensuring global operational compliance within Regulatory Affairs, but even more so now that Lundbeck is embarking in the IDMP readiness journey, where many technical and operational questions will have to be answered in close collaboration with several areas across the company.The processing and approval of changes in the PCR flow is a fundamental part of the process to convert a regulatory submission with labeling impact into an actual packaging material to make Lundbeck’s products available for our patients. This requires a high level of collaboration within the team as well as with several cross-functional stakeholders within the company or from our partners.In Lundbeck, our commitment is embedded in our Danish heritage, our solid foundation ownership and our culture of innovation. To us, it is essential that Lundbeck is a place where you grow and thrive both personally and professionally.Together, we are creating a brighter future for people living with brain diseases. That is our promise to each other and to the world.  Lundbeck offers a great workplace that is based on a flat structure, forming acollaborative working environment based on respect and equality. We employ dedicated colleagues and encourage continuous development. Together, we create the ideal conditions for you and your job, so we can create better conditions for patients.Highlights from responsibilitiesAs line manager for the RIS and PCR teams, you will be responsible for: Setting business objectives in alignment with overall company and area strategic goals.Ensuring processes and systems are in compliance with applicable global and internal requirements.Direct involvement in procedural aspects and strategic discussions in close collaboration with RBO management group.Prioritising activities and allocating resources in alignment with RBO Head. Individual performance management and skill/competence development to ensure successful delivery according to business objectives.Planning and consolidating section budget   Example on professional and/or interpersonal competencies Our preferred candidate has the following personal and professional qualifications: Education within Life science or Information science.Relevant experience within regulatory operations, data or packaging management.Prior leadership experience, not necessarily as line manager.High quality, structured and detail-oriented mindset. High collaborative, interpersonal attitude coupled with self-driven, proactive approach. Proficient in working with IT systems and databases.Flexible and thrive in a fast-paced environment with frequent tight deadlines.  Fully proficient in English.   Want to learn more?For further information, please contact Paolo Voltolina, Head of Regulatory Business Operations, on PAVT@Lundbeck.com. Your application and CV should not be sent via email. We also recommend that you have a look at our website, LinkedIn and Instagram. Sounds interesting?Please click on the apply button. Applications must be received no later than 31 July 2022  

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