Senior CMC Regulatory Sciences Specialist

Regeneron Pharmaceuticals

1d • $78,700 - $150,600 • Onsite

About The Position

We are seeking a highly motivated and experienced CMC Regulatory Sciences Specialist to join our dynamic team. This role will involve managing Chemistry, Manufacturing, and Controls (CMC) regulatory strategies across clinical and commercial phases, ensuring compliance with US and international regulatory requirements. The ideal candidate will possess strong technical writing skills, a proactive approach, and the ability to work collaboratively with cross-functional teams.

Requirements

• Experience in regulatory writing, technical writing (non-SOP related), or pharmaceutical development documentation
• Strong knowledge of CMC regulatory requirements, FDA regulations, ICH guidelines, and Current Good Manufacturing Practices.
• Excellent written and verbal communication skills, particularly in technical writing.
• Strong project management, critical thinking, and problem-solving skills.
• Ability to work independently and within a team, adapting to shifting priorities and strategies.
• BS/BA degree in a scientific discipline
• 5 years of relevant experience (for Senior CMC Regulatory Sciences Specialist)
• 8 years of relevant experience in a biopharmaceutical and/or CMC regulatory or industry setting (for Principal CMC Regulatory Sciences Specialist)

Nice To Haves

• Experience in managing CMC submissions for clinical and commercial phases preferred.
• Advanced degree preferred (MS or PhD). May consider equivalent combination of education and experience.

Responsibilities

• Develop and execute CMC regulatory strategies for clinical trial applications, amendments, commercial submissions, and marketing applications globally.
• Prepare and oversee the coordination and compilation of CMC dossiers, including Module 3: Quality, ensuring alignment with applicable regulations and guidelines.
• Author, review, and finalize CMC documents and responses to inquiries from global health agencies, maintaining submission timelines.
• Develop submission strategies, including timelines, approaches, and defining deliverables, while maintaining clear communication with stakeholders.
• Stay informed on regulatory trends, agency feedback, and global best practices, updating submission processes accordingly.
• Collaborate with cross-functional teams and external partners to ensure alignment between regulatory submissions and product supply plans.
• Engage with regulatory authorities as needed to support CMC-related modules and submissions.

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: Senior