We are currently looking to fill a Commercial Post Approval CMC Regulatory Sciences Specialist position responsible for providing Chemistry, Manufacturing, and Controls (CMC) support across Regeneron’s sites. Routine activities include dossier development for initial global marketing applications, post approval variations, and other regulatory submissions.
In this role, a typical day might include the following:
- Preparing and reviewing global CMC documents and sections for a variety of commercial biopharmaceutical regulatory submissions, verifying that all submissions are complete, accurate and meet relevant requirements.
- Handling and coordinating the authoring, review and finalization of CMC documents and responses to CMC-related inquiries from regulatory agencies, in accordance with submission timelines, keeping all team members, including third-party partners, advised of progress.
- Collaborating and developing excellent relationships with functional area and cross functional teams, contract manufacturing organizations and global Regulatory partners.
- Applying in-depth understanding of regulatory guidance and regulations, as well as industry and government agency standard processes and trends.
- Reviewing relevant CMC documents and reports for completeness, accuracy and compliance with regulations and regulatory guidance.
- Proactively identifying issues and contributing to the development of appropriate strategies to mitigate risk.
- Assisting in preparation for meetings with global regulatory authorities.
- Contributing to developing CMC regulatory strategy.
This role may be for you if you have:
- Excellent written and verbal communication skills.
- An ability to work independently, prioritize, coordinate, and complete multiple projects within deadlines while maintaining a level of attention to detail.
- Knowledge of global CMC registration and life cycle management regulations and guidelines (e.g., FDA regulations and ICH guidelines) as well as an understanding of cGMPs (Current Good Manufacturing Practices).
- Strong skills in planning, critical thinking, and problem-solving.
To be considered for the CMC Regulatory Sciences Specialist role, you must have a BA/BS degree, preferably in a scientific related field and
- Associate CMC Reg Sci Specialist: 0-2+ years
- CMC Reg Sci Specialist: 2+ years
- Senior CMC Reg Sci Specialist: 5+ years
- May consider experience in lieu of education; level decided upon completion of an interview process
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and 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. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
Salary Range (annually)