Regeneron is hiring an Associate CMC Regulatory Sciences Specialist to join our dynamic CMC Regulatory Sciences team. The successful candidate will play a critical role in overseeing the Chemistry, Manufacturing, and Controls (CMC) aspects of commercial submissions, ensuring compliance with global regulatory standards. Routine activities include dossier development for initial global marketing applications, commercial post-approval updates, and other regulatory submissions. Strong technical writing skills are essential for effectively communicating complex scientific information.
In this role, a typical day might include the following:
- Drafting and reviewing global CMC documents and sections for a variety of commercial biopharmaceutical regulatory submissions, ensuring 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 to written work and strategy.
- Reviewing relevant CMC documents and reports for completeness, accuracy and compliance with regulations and regulatory guidance.
- Proactively identifying risks and contributing to the development of appropriate strategies to mitigate them.
- 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.
- Ability to work independently, prioritize, coordinate and complete multiple projects within deadline while maintaining a level of attention to detail.
- Strong skills in planning, critical thinking and problem-solving.
- Knowledge of drug development regulations and guidelines (i.e., FDA regulations and ICH guidelines) as well as an understanding of CGMPs (Current Good Manufacturing Practices). Preferred, but not required.
In order to be considered for this position, you must hold a BS/BA degree in a scientific discipline. Advanced degree preferred.
- Associate CMC Regulatory Sciences Specialist: 0-2 years of relevant experience in a biopharmaceutical and/or CMC regulatory or industry setting
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.
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.
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What We Do
At Regeneron we believe that when the right idea finds the right team, powerful change is possible. As we work across our expanding global network to invent, develop and commercialize life-transforming medicines for people with serious diseases, we’re establishing new ways to think about science, manufacturing and commercialization. And new ways to think about health. Connect with us so we can learn more about you, and you can learn more about our biopharmaceutical medicines. And join us, as we build a future we believe in.
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