Associate CMC Product Quality Compliance Specialist

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

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