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 ContributeManage all Regulatory Compliance functions and coordination of all activities of the Regulatory Compliance Team of QA Specialists and Quality Executives.Provide 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 liaise with Global Regulatory Affairs (GRA), out-licensed partners, Contract Manufacturing Business (CMB) Quality, and divested parties to support regulatory submissions and renewals.Ensure local compliance with globally and partner-managed regulatory dossiers.Support managing CMB and partnerships for the site.Act as Subject Matter Expert (SME) on TILB change controls and API Site Change controls impacting TILB, for local regulatory compliance evaluations.Prepare TIL Bray variation submissions and communicate with HPRA.Be a formal contact point with the HPRA, the FDA, and other Pharmaceutical Authorities.Present during immediate and routine Regulatory Inspections by the U.S. FDA and the HPRA.Assist in the investigation into non-conformances and conduct regulatory compliance reviews.Help develop the existing Quality Department and personnel to deliver high-quality service in Regulatory Compliance.Represent the Quality Department on teams.Manage, direct, mentor, and motivate subordinate staff.Support GMP-related training.Support the operations of Takeda Ireland to ensure pharmaceutical products meet required standards.Participate in the recruitment and training process for Quality Department personnel.Support Agile site projects.General ResponsibilitiesParticipate in any training plans.Promote the corporate values of Takeda-ism within the workplace.Foster a culture of safety awareness and ensure timely completion of all SOP, reading, training, and assessment.Complete other tasks as directed by the relevant Director or Officer appointed by the Board of Directors.What You Bring To TakedaDegree in a science discipline is necessary.Completion or participation in a training program to obtain an educational background that meets the requirements of Article 49 of Directive 2001/83/EC (desirable).Regulatory Affairs Qualification is desirable.Minimum 5 years' experience in the Pharmaceutical Industry.Minimum 3 years of Quality Assurance-related experience.Minimum 2 years of experience in a supervisory role.Project Management & Organizational skills.Investigational and technical writing skills.Demonstrated support and respect for all departments.Promote teamwork by fostering a supportive and inclusive team atmosphere.What Takeda Can Offer YouGreat 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 shift work 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 like Dental Insurance, Partner Life Insurance, Serious Illness Protection, Fuel Card, Bike to Work, Commuter Ticket, and Insurance Deals.More About UsTakeda 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 areas, 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 and rapid change. Over the past two years, Takeda Ireland has invested over €55 million to develop our manufacturing sites, solidifying our commitment to our people and contributing to the local economy. Takeda in Ireland has commercial operations, corporate services, and manufacturing facilities across four locations: Baggot St, Bray, Citywest, and Grange Castle. We have been certified as a Top Employer for several consecutive years.How We Will Support YouTakeda is proud of its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to ethnicity, colour, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law. If you are living with disabilities, chronic illness, or neurodiversity, please feel free to let us know so that we can provide you with appropriate support during the application process.LocationsBray, IrelandWorker TypeEmployeeWorker Sub-TypeFixed TermTime TypeFull time #J-18808-Ljbffr