The CMC Regulatory Affairs Specialist performs regulatory assessment of changes. Changes include raw materials, components, manufacturing, facilities, analytical testing, and labeling to determine regulatory impact and associated submission requirement for clinical and commercial regulatory filings, in accordance with country specific regulatory guidance documents. This involves collaborative working with CMC RA and many cross-functional teams to support quality and strategy timelines. This involves collaborative working with CMC RA and many cross-functional teams to support quality and strategy timelines.A typical day might include the following:
This role might be for you if:
Attend CC associated cross-functional meetings as directed by line manger
Coordinate the assessment of internal change control affecting single to multiple products
Participate in the assessment of internal change controls
Participate in the assessment of change notifications provided by suppliers of materials, components and 3rd party testing services
Participate in the assessment of change notifications provided by CMOs and Partners
Participate in the identification of opportunities for continuous improvement and lessons learned
Participate in the implementation of improvements
You have the ability to communicate with clarity and precision.
You are open and receptive to change while looking for opportunities to continuously improve processes.
You have a strong understanding of quality principles in a regulated manufacturing environment.
To be considered for this opportunity, you must have at minimum a Bachelor’s degree in a relevant technical, scientific discipline with a 2+ years pharmaceutical/biotech industry experience, including a minimum of 2+ years of relevant CMC experience.
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)
$63,500.00 - $103,700.00