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CMC Product Quality Compliance Specialist (Regulatory Communications)

Job Description

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The CMC Product Quality Regulatory Communications team is hiring! This team is responsible for being the primary Quality representative for product deviation and market action reporting and procedures for US, EU, and Rest of World (RoW) markets. This role supports the development, coordination, and ownership of the quality and compliance elements of global regulatory communication/reporting regulations, including oversight of product deviations and product complaints, maintenance and evolution of applicable Regeneron procedures, and collaboration with partners and CMOs. Works collaboratively with CMC team members, alliance partners, Responsible Persons (RPs), Qualified Persons (QPs), and complaint and deviation teams to ensure timely strategy and reporting for reportable events on impacted product.

Essential Duties and Responsibilities may include, but are not limited to, the following:

  • Responsible for providing writing and strategy support in communications to regulatory agencies including product deviation reports (BPDR, QDR, DPR, etc.), clinical notice of events and agency inspection responses in collaboration with CMC RA, QA, and SMEs as applicable.

  • Assesses and documents regulatory reputability requirements for product complaints and deviations

  • Handles and documents Market Action assessments

  • Supports documentation updates in parallel with globalization of Regeneron-owned markets

  • Interacts with global regulatory authorities in support of the CMC activities during Agency inspections.

  • Support launch readiness and distribution compliance through ensuring appropriate GMP source documentation is in place to support regulatory activities

  • Develops procedures and systems for enhanced tracking of global regulatory reporting

  • Drives relationship management with other areas of Regulatory, Quality, Manufacturing, and Supply organizations to assess product deviation reporting

To be considered for this role, you must hold a BS/BA degree in Chemistry, Biology, or related field, and the following amounts of proven experience for each level:

  • Specialist: Requires 2+ years

  • Senior Specialist: Requires 5+ years

May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.

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Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!

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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

Salary Range (annually)

$65,100.00 - $124,300.00