Job Description
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 DescriptionQuality Regulatory Compliance ManagerAre you looking for a patient-oriented, innovation-driven company that inspires you and promotes your career? Then take your future in your hands and become part of Takeda as a Quality Regulatory Compliance Manager.Takeda's presence in Ireland was established in 1997 and our Irish operations have played a role in our global leadership in rare diseases, oncology, and gastroenterology. Since beginning commercial operations, Takeda Ireland has grown in strength thanks to substantial investment in our people and industry-leading technology.How you will contribute:Manage all Regulatory Compliance functions and coordination of all activities of the Regulatory Compliance Team of QA Specialists and Quality Executives.Site support for Global Regulatory Affairs (GRA) especially with regard to the Registration of new products (NDAs, SNDAs), supply of Clinical trials, Product Stability Programmes, and the Launch of New Products to markets.Support and liaison with Global Regulatory Affairs (GRA), out-licensed partners, Contract Manufacturing Business (CMB) Quality, and divested parties to support regulatory submissions and renewals for our and divested products.Local compliance to the globally and partner-managed regulatory dossiers.Support for managing CMB and partnerships for the site.Be Subject Matter Expert (SME) on TILB change controls and API Site Change controls which impact TILB.Prepare TIL Bray variation submissions and communication with HPRA.Be a formal contact point with the HPRA, the FDA, and other Pharmaceutical Authorities.Present for both immediate and routine Regulatory Inspections by the U.S. FDA and the HPRA.Help with the investigation into non-conformances and accomplish regulatory compliance review of non-conformances.Help to develop the existing Quality Department and personnel.Represent Quality Dept. on teams.Manage, direct, mentor, and motivate subordinate staff.Support GMP related training.Support the Operations of Takeda Ireland.Take an active role in the recruitment programme and training process for Quality Department personnel.Manage and motivate subordinate staff.Support Agile site projects.General Responsibilities:Participate in any training plans.Promote the corporate values of Takeda-ism within the workplace.Foster a culture of safety awareness.Ensure timely completion of all SOP, reading, training, and assessment.Other tasks as directed by the relevant Director or Officer appointed by the Board of Directors.What you bring to Takeda:Degree in science discipline is necessary.Completion or participation in a training program to obtain suitable educational background that meets the requirements of Article 49 of Directive 2001/83/EC (desirable requirement).Regulatory Affairs Qualification is desirable.Minimum 5 years' experience in the Pharmaceutical Industry.Minimum 3 years Quality Assurance related experience.Minimum 2 years' experience in a supervisory role.Project Management & Organizational skills.Investigational and technical writing skills.Support and respect to all departments.Promote teamwork by fostering a supportive and inclusive team atmosphere.What Takeda can offer you:Great compensation package and performance-based bonus.Employer retirement plan contributions.Employee Stock Purchase Plan.Revenue approved profit share scheme.Employer funded income protection.Employer funded private medical insurance with dependants' cover.Employer life insurance contributions.Electric charging points available at parking locations.Employee Assistance Program.Wellbeing and engagement teams.Takeda Resource Groups.Flexible schedule, e.g., hybrid or shiftwork with shift allowance.Family friendly policies.26 vacation days plus additional days for service milestones.Educational programs and formal training.Development opportunities.Humanitarian volunteering leave options.Subsidized canteen.Flexible employee funded options.More about us:Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and departments, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience, and vaccines.Takeda Ireland was established in 1997. Our story in Ireland is one of substantial growth, rapid change. Over the past two years, Takeda Ireland has invested over €55 million in Ireland to develop our manufacturing sites. Takeda in Ireland has commercial operations, corporate services, and manufacturing facilities across four locations.How we will support you:Takeda is committed to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to any characteristic protected by law.LocationsBray, IrelandWorker TypeEmployeeWorker Sub-TypeFixed Term (Fixed Term)Time TypeFull time #J-18808-Ljbffr