Description du poste
We are seeking a highly motivated and experienced CMC Regulatory Sciences Specialist to join our dynamic team. This role will involve managing Chemistry, Manufacturing, and Controls (CMC) regulatory strategies across clinical and commercial phases, ensuring compliance with US and international regulatory requirements. The ideal candidate will possess strong technical writing skills, a proactive approach, and the ability to work collaboratively with cross-functional teams.
As a Senior CMC Regulatory Sciences Specialist, a typical day might include the following:
- Develop and execute CMC regulatory strategies for clinical trial applications, amendments, commercial submissions, and marketing applications globally.
- Prepare and oversee the coordination and compilation of CMC dossiers, including Module 3: Quality, ensuring alignment with applicable regulations and guidelines.
- Author, review, and finalize CMC documents and responses to inquiries from global health agencies, maintaining submission timelines.
- Develop submission strategies, including timelines, approaches, and defining deliverables, while maintaining clear communication with stakeholders.
- Stay informed on regulatory trends, agency feedback, and global best practices, updating submission processes accordingly.
- Collaborate with cross-functional teams and external partners to ensure alignment between regulatory submissions and product supply plans.
- Engage with regulatory authorities as needed to support CMC-related modules and submissions.
This role may be for you if you have:
- Experience in regulatory writing, technical writing (non-SOP related), or pharmaceutical development documentation
- Strong knowledge of CMC regulatory requirements, FDA regulations, ICH guidelines, and Current Good Manufacturing Practices.
- Experience in managing CMC submissions for clinical and commercial phases preferred.
- Excellent written and verbal communication skills, particularly in technical writing.
- Strong project management, critical thinking, and problem-solving skills.
- Ability to work independently and within a team, adapting to shifting priorities and strategies.
In order to be considered for this position, you must hold a BS/BA degree in a scientific discipline and
- Senior CMC Regulatory Sciences Specialist: 5 years of relevant experience
- Principal CMC Regulatory Sciences Specialist: 8 years of relevant experience in a biopharmaceutical and/or CMC regulatory or industry setting
- Advanced degree preferred (MS or PhD). May consider equivalent combination of education and experience. Level is determined based on qualifications relevant to the role.
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.
Salary Range (annually)