Associate Manager CMC Regulatory Affairs

Regeneron Pharmaceuticals • Sleepy Hollow, IL

1d • Onsite

About The Position

The Associate Manager – CMC Regulatory Submissions Compliance supports the management of Clinical Trial Application (CTA) preview processes within CMC Regulatory Affairs. A Typical Day Contribute to and coordinate the CTA pre-submission review process? to ensure consistent CMC information across global submissions and prevent clinical lot release issues. Support regulatory release and QP certification by helping generate regulatory submission forms and related documentation. Participate in cross-functional meetings to identify and resolve CMC regulatory issues in clinical trial submission documents. Facilitate timely communication between IOPS and global development stakeholders. Represent CMC Regulatory Affairs in meetings with CROs to ensure submission requirements are met; provide consistent metrics and feedback on CTA processes and procedures. Help develop procedures and systems to enhance tracking of global regulatory submission packages and approval status. Keep management and stakeholders informed of assessments, strategies, risks, and project status. Contribute to training programs and knowledge-sharing across teams. This Role Might Be for You If You Have; Ability to build collaboration and teamwork across cross-functional teams. Comfort working in ambiguity and delivering results with minimal direction. A track record of positive relationship-building internally and externally. Strong communication and negotiation skills. Openness to change and a continuous improvement mindset. Understanding of quality principles in a regulated manufacturing environment.

Requirements

• BS/BA in Chemistry, Biology, or a related field (advanced degree preferred).
• 5+ years of experience in biopharmaceutical manufacturing or a related industry, including regulatory or compliance activities.
• Strong compliance background preferred; program management experience is a plus.
• Ability to build collaboration and teamwork across cross-functional teams.
• Comfort working in ambiguity and delivering results with minimal direction.
• A track record of positive relationship-building internally and externally.
• Strong communication and negotiation skills.
• Openness to change and a continuous improvement mindset.
• Understanding of quality principles in a regulated manufacturing environment.

Responsibilities

• Contribute to and coordinate the CTA pre-submission review process to ensure consistent CMC information across global submissions and prevent clinical lot release issues.
• Support regulatory release and QP certification by helping generate regulatory submission forms and related documentation.
• Participate in cross-functional meetings to identify and resolve CMC regulatory issues in clinical trial submission documents.
• Facilitate timely communication between IOPS and global development stakeholders.
• Represent CMC Regulatory Affairs in meetings with CROs to ensure submission requirements are met; provide consistent metrics and feedback on CTA processes and procedures.
• Help develop procedures and systems to enhance tracking of global regulatory submission packages and approval status.
• Keep management and stakeholders informed of assessments, strategies, risks, and project status.
• Contribute to training programs and knowledge-sharing across teams.

Benefits

• health and wellness programs (including medical, dental, vision, life, and disability insurance)
• fitness centers
• 401(k) company match
• family support benefits
• equity awards
• annual bonuses
• paid time off
• paid leaves (e.g., military and parental leave)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level