Find Regulatory specialist Jobs in County Limerick

Associate CMC Product Quality Compliance Specialist
Regeneron —County Limerick
- €37,000–€59,400 a year
- Analysis skills
- Supervising experience
- Bachelor's degree
- Annual leave
1d
Senior Quality Compliance Specialist
Regeneron —County Limerick
- €54,200–€88,400 a year
- Bachelor's degree
- No degree
- In-person
- Annual leave
7d
AML/KYC Quality Control and Testing Specialist
Northern Trust Corp. —Limerick, County Limerick
- Full-time
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
13d
Specialist, Investment Risk
Northern Trust Corp. —Limerick, County Limerick
- Finance
- Master's degree
- Bachelor's degree
Principal QA Specialist - IT
Regeneron —County Limerick
- €63,200–€103,200 a year
- Engineering
- Bachelor's degree
- Annual leave
Senior External Manufacturing Specialist
Regeneron —County Limerick
- €46,200–€88,400 a year
- Microsoft Powerpoint
- Microsoft Excel
- Bachelor's degree
- Annual leave
1d
AML/KYC Risk Management and Outsourcing Specialist
Northern Trust Corp. —Limerick, County Limerick
- Full-time
- Microsoft Powerpoint
- Microsoft Excel
- Analysis skills
13d
GMP Data Governance & Engagement Lead
Regeneron —County Limerick
- Analysis skills
- Bachelor's degree
- Annual leave
21h
Clinical Nurse Specialist Medical Oncology - Limerick Cancer Centre
UPMC —Limerick, County Limerick
- €62,077.17–€76,158.63 a year
- Microsoft Powerpoint
- Microsoft Word
- Nursing
- Annual leave
Audit Manager - Non FS - Limerick
PwC —Limerick, County Limerick
- Full-time
- Accounting
Consultant, Private Equity Accounting - Limerick | Hybrid
Northern Trust Corp. —Limerick, County Limerick
- No degree
- Accounting
Software Architect
AMCS Group —Limerick, County Limerick
- Full-time
- Hybrid work
- Azure
- Computer Science
- Master's degree
Quick apply
Clinical Nurse Manager III
Bon Secours Health System Ireland —Limerick, County Limerick
- Weekend availability
- Management
- Leadership
- Communication skills

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Find similar jobs that you might be interested in.

Senior Quality Compliance Specialist
Regeneron —County Limerick
Specialist - BS/BA in scientific discipline or related field with 2+ years of relevant work experience in pharmaceutical or related industry or equivalent…
€54,200–€88,400 a year
7d
Senior External Manufacturing Specialist
Regeneron —County Limerick
Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans…
€46,200–€88,400 a year
1d

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Associate CMC Product Quality Compliance Specialist

Regeneron -
County Limerick

Apply Now

Job details

€37,000–€59,400 a year
1 day ago

Benefits

Annual leave

Qualifications

Biology
Analysis skills
Supervising experience
Bachelor's degree
Organisational skills
Chemistry
Leadership

Full job description

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Regeneron is currently seeking an Associate CMC Product Quality Compliance Specialist to join our Quality Assurance team.

This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:

Location: Raheen, Limerick

What you’ll do:

Overseeing the global change management implementation plan.
Supporting the evaluation of impact of proposed process changes, deviations and CAPAs on the end-to-end supply chain.
Overseeing the coordination and generation of the annual PQRs and yearly biologic product reports (YBPR).
Assessing quality-related information to detect trends and work with subject matter experts to determine the need for actions required in response to those trends.
Ensuring the drug supply distribution compliance with all aspects of global regulatory filings to ensure stable supply positioning.
Interacting with global regulatory authorities in support of the CMC activities during Agency inspections.
Executing relationship management with other areas of Regulatory, Quality, Manufacturing, and Supply organizations to support product distribution.
Developing procedures and systems for enhanced tracking of change controls and global regulatory submissions/approvals.
Supporting launch readiness and distribution compliance through ensuring appropriate GMP source documentation is in place to support regulatory activities and launch material is aligned with the applicable regulatory dossiers.
Providing writing and strategy support in communications to regulatory agencies including product deviation reports (BPDR, QDR, PDR, etc.), clinical notice of events and agency inspection responses in collaboration with CMC RA, QA, and SMEs as applicable.
Facilitating the commercial and registration requests (CARRs) process in collaboration with CMC PM, CMC RA, IMT and SMEs as applicable.

The environment and physical rhythms of this role:

You have excellent interpersonal skills.
You demonstrate a strong quality mindset.
You have strong analytical and organizational skills.

Let’s find out if we’re a fit:

Assoc Specialist: Requires BS/BA in Chemistry, Biology, or related field, with relevant experience or equivalent combination of education and experience, preferably pharmaceutical or medical device, including some supervisory and/or leadership experience.
Specialist: Requires BS/BA in Chemistry, Biology, or related field, with 2+ years of relevant experience in pharmaceutical or medical device, including some supervisory and/or leadership experience or equivalent combination of education and experience.
Sr Specialist: Requires BS/BA in Chemistry, Biology, or related field, with 5+ years of relevant experience in pharmaceutical or medical device, including some supervisory and/or leadership experience or equivalent combination of education and experience.

Thrive today. Grow tomorrow.

#IRELIM #JOBSIEST #LI-Onsite #REGNIRLQA

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

€37,000.00 - €59,400.00

Apply Now

Refine Your Search

regulatory specialist jobs in county limerick

Associate CMC Product Quality Compliance Specialist

Senior Quality Compliance Specialist

AML/KYC Quality Control and Testing Specialist

Specialist, Investment Risk

Principal QA Specialist - IT

Senior External Manufacturing Specialist

AML/KYC Risk Management and Outsourcing Specialist

GMP Data Governance & Engagement Lead

Clinical Nurse Specialist Medical Oncology - Limerick Cancer Centre

Audit Manager - Non FS - Limerick

Consultant, Private Equity Accounting - Limerick | Hybrid

Software Architect

Clinical Nurse Manager III

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When & where:

What you’ll do:

The environment and physical rhythms of this role:

Let’s find out if we’re a fit:

Thrive today. Grow tomorrow.

#IRELIM #JOBSIEST #LI-Onsite #REGNIRLQA

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