• CMC
• Documentation
• Filings
• GMP
• Inspections
• Life Science
• Relationship Management

CMC Product Quality Compliance Coordinator

Pay Range: $22 - $24/hr

Onsite Role in Rensselaer, NY

This position is responsible for being the primary Quality representative for product and distribution compliance of Regeneron’s commercial programs. This role supports the development, coordination and ownership of the quality and compliance elements of the life cycle strategy, including pre-commercialization activities, end-to-end optimization efforts and overseeing product management activities. Works collaboratively with CMC team members and cross-functionally to ensure compliance of product, continuity of supply, consistency within and across programs, and supply strategy alignment across functions

As a CMC Product Quality Compliance Coordinator, a typical day might include the following:

• May support launch readiness and/or post approval 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.
• Ensures drug supply distribution compliance with all aspects of global regulatory filings to ensure stable supply positioning.
• Collaborates cross-functionally to support regulatory release process.
• Supports the evaluation of impact of proposed process changes, deviations and CAPAs.
• Assesses quality-related information to detect trends and works with subject matter experts to determine the need for actions required in response to those trends
• Interacts with global regulatory authorities in support of the CMC activities during Agency inspections.
• Executes relationship management with other areas of Regulatory, Quality, Manufacturing, and Supply organizations to support product distribution.
• Develops procedures and systems for enhanced tracking of change controls and global regulatory submissions/approvals.

To be considered you must have the following:

 BS/BA in a life science field.

This is a contract position at Regeneron with Magnit Global being the Employer.

To do our best work we need different viewpoints.  Therefore, we celebrate diversity and embrace inclusion. As an equal opportunity employer, we are dedicated to building a team that represents a variety of backgrounds, perspectives, and skills.  We strive to ensure that we maintain a positive and enriching work environment for all.

W2 only, no third party solicitation

• Work Authorization : Green Card, US Citizen
• Preferred years of experience : No preferred years of experience required
• Travel Required : No travel required
• Shift timings: 9 AM to 5 PM