Regulatory Compliance Specialist
This role is a critical part of our regulatory compliance team. You will oversee the Chemistry, Manufacturing, and Controls aspects of commercial submissions to ensure global regulatory standards are met. Drafting and reviewing global CMC documents and sections for commercial biopharmaceutical regulatory submissions, handling authoring, review, and finalization of CMC documents and responses to inquiries from regulatory agencies.
Key Responsibilities:
* Drafting and reviewing global CMC documents and sections
* Handling and coordinating authoring, review, and finalization of CMC documents and responses to inquiries
* Collaborating with functional area and cross-functional teams, contract manufacturing organizations, and global Regulatory partners
* Applying in-depth understanding of regulatory guidance and regulations to written work and strategy
The ideal candidate will possess excellent written and verbal communication skills, ability to work independently, prioritize, coordinate, and complete multiple projects within deadline while maintaining attention to detail.
About This Opportunity
We seek a skilled professional with a strong background in scientific discipline, relevant experience in biopharmaceutical and/or CMC regulatory or industry setting. A Bachelor's degree in Life Sciences is required, along with a minimum of 2 years of experience as a specialist. Senior specialist level requires 5 years of experience.
This role offers an inclusive and diverse culture, comprehensive benefits, including health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off. Regeneron is committed to diversity and inclusion, providing equal opportunities for all employees.
Benefits and Perks
We offer a competitive compensation package, including comprehensive health insurance, 401(k) plan, and paid time off. Our employee-focused programs include mentorship, training, and career development opportunities.