Johnson & Johnson
JSI Regulatory QA Specialist
JSI Regulatory QA Specialist
Location: Ringaskiddy Cork, Ireland - Hybrid working - 3 days a week on site
Duration: 11 months
Hours: 39 hours per week
The JSI Regulatory QA Specialist is responsible for executing regulatory and compliance related tasks and project activities supporting both the Quality Assurance and Global Regulatory Affairs departments functions. The JSI Regulatory QA Specialist is responsible for completing regulatory requests for JSI in conjunction with the Regulatory QA Team Lead.
roles and responsibilities.
Maintenance of the Clinical and Commercial Health Products Regulatory Authority (HPRA) Manufacturing Licenses by preparing and submitting application updates in a timely manner.
Collaborate effectively with Notary Public on the management of notarisation and legalisation requests. Ensure availability of related PO’s and appropriate logging and tracking of requests.
Assist and co-ordinate with Regulatory Management on Country Specific Requests (CSRs) for initial registrations and renewals.
Co-ordinate paper-based inspections for product renewals and new submissions as per Health Authority timelines.
Support new submissions for Cork products by reviewing relevant dossier sections, participating in issue escalation and ensuring Cork specific license sections are reviewed appropriately and workflows are appropriate.
Support post-approval submissions for Cork products by preparing and/or reviewing relevant dossier sections, participating in issue escalation and coordinating country specific requests associated with post-approval changes e.g. scale ups, addition of new technologies.
Assist and support onsite Health Authority inspections and internal audits as required.
Co-ordinate Japanese specific requirements (co-ordination of the Site Accreditation and notification to JPKK, co-ordination of Consistency Checks in accordance with required timelines and co-ordination and/or support of Japan BQ inspections).
Co-ordinate Taiwan specific requirements (co-ordination of the Site Accreditation and notification to TFDA, co-ordination and/or support of Taiwan inspections).
Co-ordinate China specific requirements (co-ordination of Consistency Checks in accordance with required timelines and co-ordination and/or support of China BQ inspections).
In conjunction with Regulatory QA Team Lead/Quality Management, provide support in relation to JSI operational issues e.g. reprocessing, MDLDs as required.
Maintenance of Regulatory Playbook and associated job cards in collaboration with Regulatory QA Team Lead.
Support Regulatory QA Team Lead with the preparation and review of change summaries for each of the products in support of the Annual Reports (ARs).
Familiarisation with license content and license sections in docuBridge.
Support Regulatory QA Team Lead/Quality Management to plan, complete and front load workload.
Attend local change control board and complete change control assessments, as required.
Support Regulatory QA Team Lead in development of Regulatory and Project Strategies.
Support Site Master File review and update.
Key Skills and Competencies required:
Excellent interpersonal skills
Collaboration and teamwork
Customer focused
Innovative
Excellent communication skills both written and verbal
Attention to detail
Good problem-solving skills
Results and performance driven
Adaptable and flexible
Decision making
Knowledgeable on regulatory systems
Organizational skills
how to succeed.
Essential:
Bachelor’s Degree in a Scientific/Technical discipline required
A minimum of 3 years’ experience in a quality, manufacturing, validation or compliance role within biological and/or pharmaceutical industry.
Up to date knowledge of relevant pharmaceutical Legislation, Directives and Regulations, in particular FDA/EMA regulatory requirements applicable to biologics and/or pharmaceuticals.
Ability to apply GMP and GDP regulations and international guidelines to all aspects of the position.
Desirable:
Previous experience working as a Regulatory Specialist.
Post-graduate degree specific to Regulatory Affairs (Diploma/Masters).
benefits.
This role offers a very competitive hourly rate. This contract will run for 11 months
you are welcome here.
Johnson & Johnson is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.
about Johnson & Johnson Innovative Medicine
Patients inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science and compassion, we confidently address some of the most complex diseases of our time and unlock the potential medicines of tomorrow. Our diverse portfolio spans multiple therapeutic areas — Oncology, Immunology, Neuroscience, Cardiovascular, Pulmonary Hypertension, and Retina. We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way.
application process.
We are looking to process the first round of applications within the next 2 working days. We do not accept applications via email or LinkedIn InMail - you must apply direct to this advert.
Diversity, Equity & Inclusion.
For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.