Sr CMC Regulatory Sciences Specialist at Regeneron Pharmaceuticals, Inc.

We are currently looking to fill a Sr CMC Regulatory Sciences Specialist position. This position is responsible for providing Chemistry, Manufacturing, and Controls (CMC) submission writing and support across Regenerons sites. Routine activities include overseeing, generating, and reviewing technical documentation supporting pharmaceutical regulatory submissions.

In this role, a typical day might include but are not limited to, the following:

• 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, while keeping all stakeholders, including external partners, informed of progress.

• Applies in-depth understanding of regulatory guidance and regulations, as well as industry and government agency standard processes and trends.

• Helps to build process knowledge base, knowledge management and lessons learned, including identification of continuous improvement activities to improve processes.

• Performs review of manufacturing documentation, technical reports, and protocols to support regulatory submissions.

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

• May involve supervision of technical specialists.

This role may be for you if:

• Strong written and verbal communication skills.

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

• Continuously drive to improve processes for improved performance.

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

• Ability to analyze and identify trends.

• Develops and delivers effective presentations.

• Critical thinking and problem-solving skills.

• Ability to train others on basic processes and concepts.

• 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).

To be considered for this position, you must hold a BA/BS degree in a scientific discipline with 5+ years of relevant experience; advanced degree is preferred with 4+ years of relevant experience. Technical writing, drug substance manufacturing process and process control strategy, manufacturing process development, or cell and gene therapy 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)