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Form of workWe expect the CMC Regulatory Affairs Specialist to join a growing team and provide support to interpret the current, approved and planned clinical regulatory landscape by giving input to the regulatory submission form process.
In this role, a typical day might include 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
Provides regulatory submission updates to cross-functional groups, as needed to support a stable clinical supply position
Maintains regulatory submission forms to support regulatory release and QP certification
Provides updates to management that need to be communicated to Regeneron's CROs to maintain that submission requirements are being met and provide consistent metrics and feedback on CTA processes and procedures
Works within the procedures and systems for enhanced tracking of submission packages and approval status
This role might be for you if:
You have a strong understanding of quality principals in a regulated manufacturing environment
You bring strong communication and program management skills
You can implement improvements to processes while having scope changes occur during the project
To be considered for the opportunity, we expect you to have at 1+ years of experience in the life science industry with a focus in biopharmaceutical manufacturing or regulatory or compliance related activities with a bachelor's degree in chemistry, Biology or related field
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)
