23 Regulatory Compliance jobs in Ireland
QA Regulatory Compliance Specialist

Posted 2 days ago
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**We are PCI.**
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
**Summary of Role**
The role is to implement and execute tasks relating to the introduction and maintenance of Clinical products within the RCT department in PCI. Role supports right first time QP release and clients in management and oversight of regulatory changes.
+ Creation and maintenance of Product Specification File (PSF) for Clinical supply chain where QP certification is performed.
+ Developing and managing Quality Systems & Compliance to support the maintenance and release of third-party supply chains at PCI.
+ Maintenance of Approved CMO list for Clinical Supply Chain
+ Ensure on-going compliance with customer, regulatory and internal requirements.
+ Management and co-ordinate Supplier Management Programme, including supplier audits, preparation and review of quality technical agreements, supplier qualification and vendor performance for third party suppliers.
+ Preparation and maintenance of the clinical approved products.
+ Preparation of QP declarations for review and approval by PCI QP
+ Support the management of the Manufacturing and Importation Licence held by Millmount entity and the associated variations to it.
+ Raise Deviations, Corrective Action Requests, and Non-Conformance reports as required in a timely manner and ensure that issues are communicated to management.
+ Generation of SOP/Forms/Job Aids/Work Instruction's on the Master Control system
+ Identify and support opportunities for improving processes and or procedures.
+ To undertake such tasks and to manage specific or ad hoc projects as and when required to meet department and business needs and within the scope of the job-holder's capabilities.
**Knowledge / Skills & Experience**
**Essential:**
+ Bachelor's degree in a scientific/technical/engineering discipline or associate degree or Diploma / Certificate. May substitute experience in lieu of educational requirements.
+ Minimum 2 years' experience working in quality, validation or compliance role within the biological and/or pharmaceutical industry.
+ Knowledgeable of EU regulatory requirements applicable to pharmaceuticals. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.
+ Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
+ Client Facing experience
**Desirable:**
+ Experience in auditing of external suppliers, contractors and vendors.
+ Experience with regulatory filings.
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future ( Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
Regulatory Compliance Manager
Posted 4 days ago
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Export Regulatory Compliance Officer
Posted 4 days ago
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Content Policy Manager, Regulatory Compliance

Posted 2 days ago
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This role sits at the intersection of tech and policy with focus on shaping compliance with new integrity and content related regulation, consistent with our principles and Corporate Human Rights commitments. In this role you will work on regulatory obligations globally, engaging with a broad set of stakeholders and subject matter experts. This is an opportunity to work on some of the most complex issues the company faces balancing voice and compliance.
**Required Skills:**
Content Policy Manager, Regulatory Compliance Responsibilities:
1. Manage regulatory escalations related to Frauds and Scams
2. Advise Product on new regulatory requirements related to Frauds and Scams
3. Act as an escalation point of contact and manage internal communications for policy issues, including on-call rotations in timezone, with potential irregular hours
4. Build relationships with and understand the perspectives of partners on internal teams, such as Integrity Reg Readiness Project, Legal, Public Policy, Human Rights Policy, Content Policy, Communications
5. Develop guidelines and strategies for local content law compliance
**Minimum Qualifications:**
Minimum Qualifications:
6. 6+ years of experience working in tech policy, law, integrity compliance, human rights, government, or risk management with an emphasis on platforms and technology
7. Expertise in regulations touching upon intermediary liability issues
8. Experience with Internet/social media content issues
9. Understanding of and experience in Meta policies and standards (eg: Facebook's Community Standards)
10. Demonstrates analytical-thinking and problem-solving skills and project management experience
11. Experience working cross-functionally and consensus-building
12. Understanding of Meta's products and principles
13. Proven communication skills
**Industry:** Internet
Compliance Specialist

Posted 2 days ago
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Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries.
Abbott serves the Irish market with a diverse range of healthcare products including diagnostics, medical devices and nutritionals products. In Ireland, Abbott employs over 6000 people across tensites. We have seven manufacturing facilities located in Clonmel, Cootehill, Donegal, Kilkenny, Longford and Sligo and a third-party manufacturing management operation in Sligo. Abbott has commercial, support operations and shared services in Dublin and Galway. We have been operating in Ireland since 1946.
**Abbott Ireland Nutrition Division Cootehill Cavan**
Abbott Nutrition produces a range of infant formulae in all pack sizes under the brand name "Similac". To complement the range of "Similac" infant formulae, the facility also manufactures a range of follow-on formulae under the brand name of "Gain". The essential ingredient is liquid skim-milk and this is combined with carbohydrate, vegetable oils, vitamins and minerals. The product is blended, pasteurised, dried and packaged at the site and once packaged, is distributed to Europe, Southeast Asia, the Middle East, Latin America and Canada.
Established in 1975, Abbott Nutrition in Ireland is the largest powder manufacturing facility for the production of infant formulae within the Abbott Corporation worldwide. Approximately 1,000 dairy farms in Ireland and Northern Ireland supply quality milk to the Cootehill facility which processes 500,000 litres per day. This secure supply together with Ireland's reputation as a green, clean environment is of significant strategic importance to Abbott Nutrition.
**PURPOSE OF THE JOB**
+ This role will provide leadership in the areas of Plant Compliance, Strategic Compliance initiatives, cGMP and Food Safety within Manufacturing. This will include a responsibility in providing direction for continuous improvement.
**MAJOR RESPONSIBILITIES**
+ Follow all Environmental, Health and Safety Rules and Regulations in the plant.
+ Report any current or potential hazards to your manager immediately.
+ Wear the correct Personal Protective Equipment (P.P.E) at all times. Consult the appropriate SOP where required.
+ Play an active role in the Food Safety Management Team with responsibility for the HACCP Programme
+ Responsibility for reviewing all SOP's for any job task he/she may carry out and ensure he/she fully understands and adheres to the SOP.
+ Lead strategic quality initiatives in the areas Compliance and other specific areas.
+ Key role in implementation and management of the audit readiness in Manufacturing
+ Develop, identify, analyse, manage and communicate compliance matrices
+ Ensuring Compliance to all Regulations/Legislation applicable to Manufacturing.
+ Develop and deliver training with regard to compliance based on business needs.
+ Play a key role in the Plant Compliance to ensure all new equipment/processes and any new infrastructure meets cGMP standards and regulatory compliance.
+ Manage the Manufacturing Department Janitorial requirements and staff.
+ Ensure compliance to all Corporate and Division Policies in the area of responsibility.
+ Benchmark activities to ensure current cGMP is consistent with Infant Formulae Nutritional Industry.
+ Responsible for auditing of the Manufacturing Department
+ Participate as a lead auditor within the plant in internal audit schedule, plant walk-downs and external audits.
+ Manage and co-ordinate bi-weekly compliance walk-down programme activities.
+ Play a key role in ensuring the plant is audit ready for CRQS, Division and regulatory audits.
+ Responsible for the oversight of the plant sanitation programme and liaising with third party cleaning contractor who have responsibility for cleaning, sanitization, Environmental Monitoring Programme and pest control.
+ Accountable for compliance to all local and US federal regulations, all applicable food safety policies and procedures.
+ Responsible for reporting of the site sanitation programme performance at monthly management review and through management activities.
+ This Job function will change where update procedures to GMP, EHS, Technical / New Equipment, Quality Procedures & SOP's are made.
+ This list of responsibilities may change depending on plant needs and employees are expected to be adaptable and flexible were this need arises.
**EDUCATION & COMPETENCIES**
+ A Diploma/Degree in Food Science/Chemistry/Quality or a Third level qualification in a related discipline.
+ Very good understanding of the manufacturing process.
+ Strong knowledge and experience in auditing, analytical techniques and methods used.
+ Excellent interpersonal skills and management skills.
+ Ability to: communicate with all levels of the organization, communicate effectively with cross-functional team.
+ This function will have responsibility to ensure that Compliance is managed effectively and will provide leadership in the areas of Manufacturing Compliance, Strategic Compliance initiatives, cGMP and Food Safety.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email
Compliance Specialist
Posted 1 day ago
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Tax Compliance Specialist
Posted 4 days ago
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Environmental Compliance Specialist Limerick
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Environmental compliance specialist limerick
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