Quality Regulatory Compliance Manager

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Job Description

Quality Regulatory Compliance Manager

Are 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 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 to 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 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, for local regulatory compliance evaluations and ensure completion of related action tasks.
• Prepare TIL Bray variation submissions and communication with HPRA
• Be a formal contact point with the HPRA, the FDA and other Pharmaceutical Authorities.
• Present us for both immediate and routine Regulatory Inspections - by the U.S. FDA. and the HPRA.
• To help with the investigation into non-conformances and accomplish regulatory compliance review of non-conformances.
• Help to develop the existing Quality Department and personnel so that a high quality of service in the fields of Regulatory Compliance can be delivered to Takeda Ireland and to the GMS/GQ Group.
• Represent Quality Dept. on teams.
• Manage, direct, mentor and motivate subordinate staff.
• Support GMP related training.
• Support the Operations of Takeda Ireland such that pharmaceutical products of the correct dose, strength, purity, efficacy and quality standard are delivered to our customers according to schedule and within budget.
• 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, in cooperation with other TIL staff, an ethos and culture of safety awareness where safety is accepted as an necessary part of the business. Ensure that Accident Reports / Near Miss Forms are completed promptly after an event.
• Ensure timely completion of all SOP, reading, training and assessment.
• Other tasks and directed by the relevant Director other Officer appointed by the Board of Directors.

What you bring to Takeda:

• Degree in science discipline is necessary .
• To have completed or be in a training program to obtain suitable educational background that meets the requirements of Article 49 of Directive2001/83/EC (desirable requirement).
• Regulatory Affairs Qualification is desirable.
• Minimum 5 years' experience in a Pharmaceutical Industry.
• Minimum 3 years Quality Assurance related experience.
• Minimum 2 years' experience in a supervisory role.
• Project Management & Organisational skills
• Investigational and technical writing skills.
• Work demonstrating support and respect to all departments.
• Promote teamwork by helping foster 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 like Dental Insurance, Partner Life Insurance, Serious Illness Protection, Fuel Card, Bike to Work, Commuter Ticket, and Insurance Deals

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, and. Over the past two years, Takeda Ireland has invested over €55 million in Ireland to develop our manufacturing sites. Solidifying our commitment in 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 Top Employer for several consecutive years.

How we will support you:

Takeda is proud of its commitment to create a diverse workforce and to provide 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.

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