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

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 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.

Qualifications

• 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.
• Excellent interpersonal skills.
• Strong quality mindset.
• Strong analytical and organizational skills.

Benefits

Benefits include a competitive total rewards package, such as annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, insurance benefits, paid time off, and family support benefits.

Salary Range

€37,000.00 - €59,400.00 annually.

Equal Opportunity Employer

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.