Senior CMC Regulatory Sciences Specialist

The specialist will collaborate on the Chemistry, Manufacturing, and Controls (CMC) regulatory strategy and authoring CMC dossiers for clinical trial applications, amendments, information request responses, and other regulatory submissions including, but not limited to monoclonal antibodies and bioconjugates.

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

• Contributes to developing CMC regulatory strategy and ensures alignment between regulatory submissions and product supply plans.
• Works with management on CMC regulatory strategy and project status.
• Collaborates and develops excellent relationships with cross functional teams, and contract manufacturing organizations.
• Prepares global CMC documents and sections for a variety of clinical regulatory submissions, ensuring that submissions are complete, accurate, and meet relevant requirements. May assist in preparation for meetings with global regulatory authorities.
• Manages and coordinates the authoring, review and finalization of CMC documents and responses to CMC-related inquiries from global health agencies, in accordance with submission timelines, keeping all collaborators including external partners advised of progress.
• Applies in-depth understanding of regulatory guidance and regulations, as well as industry and government agency best practices and trends.
• Proactively identifies issues and contributes to developing appropriate strategies to mitigate risk.

This role may be for you if you have:

• Excellent written and verbal communication skills
• A proactive and solution-oriented approach
• Strong skills in planning, critical thinking, and problem-solving
• Comfort dealing with shifting priorities and changes in strategy
• The ability to work independently and in a team
• Knowledge of drug development regulations and guidelines (i.e., FDA regulations and ICH guidelines) and an understanding of Current Good Manufacturing Practices

In order to be considered for this position, you must hold a BA/BS degree and

• 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
• Degree in a scientific field preferred, advanced degree preferred
• Experience with CMC authoring preferred

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)