Principal CMC Regulatory Sciences Specialist

Summary: Responsible for overseeing, generating and reviewing technical documentation supporting pharmaceutical regulatory submissions.

Essential Duties and Responsibilities:

• Generates and reviews technical documentation supporting regulatory submissions.

• Evaluates options to address technical challenges within regulatory submissions and presents them for endorsement.

• Gathers, trends and analyzes process generated data; summarizes findings in memos, reports and/or presentations as applicable.

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

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

• Ensures all tasks are performed in a manner consistent with regulatory guidance.

• Helps to build process knowledge base, knowledge management and lessons learned; identifies continuous improvement activities to improve processes.

• May involve supervision of technical specialists.

Education and Experience:

• Requires BS/BA degree in a scientific discipline and 8 years of experience within biopharmaceutical equipment, manufacturing and/or CMC regulatory industry or equivalent combination of education and experience.

• Advanced degree preferred (MS or PhD).

Knowledge, Skills and Abilities:

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

• Continuously drives 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.

• Problem-solving skills.

• Ability to train others on basic processes and concepts.

• Strong written communication.

• Critical thinking skills.

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)