Summary: Supports the management the CTA preview processes.
Essential Duties and Responsibilities:
Contributes to the management of CTA preview process which involves the coordination and review of documentation planned for submission to global health authorities to be sure consistency of CMC related information across the CTA to prevent issues at time of release of lots to clinical trials.
Support regulatory release and QP certification by providing support to the regulatory submission form generation process.
Participate in cross-functional meetings to help identify CMC regulatory issues related to submission documentation for clinical trials.
Ensure appropriate communication between IOPS and global development in a timely manner.
Represents CMC RA at meetings with Regeneron’s CROs to ensure all submission requirements are being met and provide consistent metrics and feedback on CTA processes and procedures.
Participates in the development of procedures and systems for enhanced tracking of global regulatory submission packages and approval status.
Keeps management and all stakeholders informed of assessments, overall strategy, and project status.
Contribute to training programs.
May manage direct reports.
Education and Experience:
• Requires BS/BA in Chemistry, Biology or related field (advanced degree preferred).
• 5+ years of experience working in the biopharmaceutical manufacturing or related industry including experience working in regulatory or compliance related activities.
• Strong compliance background preferred.
• Experience in program management a plus.
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)