CMC Regulatory Sciences Specialist

The CMC Regulatory Sciences Specialist position is responsible for providing Chemistry, Manufacturing, and Controls (CMC) submission writing and support across Regeneron's sites. Routine activities include dossier development for marketing applications, amendments, post approval variations, and other regulatory submissions.

As a CMC Regulatory Sciences Specialist, a typical day might include the following:

• Prepares global CMC documents and sections for a variety of clinical and commercial biopharmaceutical regulatory submissions, ensuring that all submissions are complete, accurate and meet relevant requirements.

• Manages and coordinates the authoring, review, and finalization of CMC documents, and responses to CMC-related inquiries from Regulatory agencies, in accordance with submission timelines, keeping all stakeholders, including external partners, informed of progress.

• Works effectively and efficiently in a team-oriented environment to ensure maximum and high-quality output.

• May review relevant CMC documents and reports for completeness, accuracy and compliance with regulations and regulatory guidance.

• May proactively identify issues and contributes to the development of appropriate strategies to mitigate risk.

• May assist in preparation for meetings with global regulatory authorities.

This role may be for you if

• Strong written and verbal communication skills.

• Critical thinking and problem-solving skills

• Ability to work independently or as part of a team.

• Ability to multi-task and work in a dynamic environment.

• Knowledge of relevant drug development regulations and guidelines (i.e., FDA regulations and ICH guidelines) as well as an understanding of CGMPs (Current Good Manufacturing Practices).

In order to be considered for this position, you must hold a BA/BS degree required, preferably in a scientific related field and

• Associate Specialist: 0-2 years of relevant experience.

• Specialist: 2+ years of relevant experience.

• Senior Specialist: 5+ years of relevant experience.

• May consider experience in lieu of education; level decided upon completion of an interview process.

• Technical writing, manufacturing process development and process controls, and/or CMC regulatory experience is a plus.

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)

$58,480.40 - $124,300.00