Senior Specialist, CMC Regulatory Affairs

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Job description

The Sr. CMC Regulatory Affairs Specialist performs regulatory assessment of changes. Interpreting the current, approved and planned clinical regulatory landscape by contributing to the regulatory submission form process.

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

• Support the regulatory submission forms to support regulatory release and QP certification.

• Foster strong communication and working relationships between IOPS and Global Development

• 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.

This role might be for you if:

• History of building and maintaining positive relationships both internally and externally.

• Strong ability to communicate at all levels with clarity and precision.

• Open and receptive to change while looking for opportunities to continuously improve processes.

• Strong understanding of quality principles in a regulated manufacturing environment helpful.

To be considered for this opportunity, you must have at minimum a Bachelors degree in a relevant technical, scientific discipline with a 4+ years pharmaceutical/biotech industry experience, including a minimum of 3+ years of relevant CMC experience.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, 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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)

$76,100.00 - $124,300.00

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