The Senior CMC Regulatory Affairs Specialist – Regulatory Submissions Compliance is responsible for interpreting the current, approved and planned clinical regulatory landscape by contributing to the regulatory submission form process.
Essential Duties and Responsibilities include, but are not limited to, the following:
• Reviews regulatory submissions to ensure all aspects of global regulatory and CMC compliance (beyond GMP compliance) are met and fully support clinical supply
• Collaborates cross-functionally to support the submission strategies and impacts on supply and regulatory release processes
• Support the regulatory submission forms to support regulatory release and QP certification.
• Foster strong communication and working relationships between IOPS and Global Development
• Can lead team huddles and clearly articulate present regulatory issues.
• May participate in creating regulatory justifications
• Keeps management and all stakeholders informed of assessments, overall strategy, and project status
• Works within the procedures and systems for enhanced tracking of global regulatory submission packages and approval status.
Education and Experience:
• Requires BS/BA in Chemistry, Biology or related field (advanced degree preferred).
• 3+ 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.
• Or equivalent combination of education and experience
Knowledge and Skills:
• History of building and maintaining positive relationships both internally and externally.
• Strong ability to communicate at all levels with clarity and precision.
• Strong attention to detail.
• Open and receptive to change while looking for opportunities to continuously improve processes.
• Strong understanding of quality principles in a regulated manufacturing environment helpful.
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)