Associate CMC Product Quality Compliance Specialist

Regeneron Pharmaceuticals, Inc; Munster; On-site; EUR 37,000 - 59,400; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking an Associate CMC Product Quality Compliance Specialist to join the Quality Assurance team in Ireland.

The role focuses on change management, regulatory submissions, and ensuring consistent product quality across the supply chain. The successful candidate will coordinate PQRs and YBPRs, assess quality data for trends, and collaborate with global regulatory bodies to support inspections and submissions.

Qualifications

• BS/BA in Chemistry, Biology, or related field with relevant experience.
• 2+ years of relevant experience in pharmaceutical or medical device sectors, with supervisory/leadership experience preferred.

Responsibilities

• Overseeing global change management implementation.
• Evaluating impact of proposed process changes, deviations and CAPAs on end-to-end supply chain.
• Coordinating and generating annual PQRs and YBPRs.
• Assessing quality information to detect trends and determining actions.
• Ensuring drug supply distribution complies with global regulatory filings.
• Interacting with global regulatory authorities during Agency inspections.
• Collaborating with Regulatory, Quality, Manufacturing and Supply teams to support distribution.
• Developing procedures for tracking change controls and submissions/approvals.
• Supporting launch readiness and ensuring GMP source documentation.

Skills

Quality mindset

Analytical skills

Organizational skills

Interpersonal skills

Education

BS/BA in Chemistry or Biology

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.

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.

Salary Range (annually)

€37,000.00 - €59,400.00