CMC Regulatory Sciences Specialist
We are currently looking to fill a Chemistry, Manufacturing and Controls (CMC) Regulatory Sciences Specialist (Clinical). Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. Our CMC Regulatory Sciences Specialists provide regulatory support across Regeneron’s sites. They assist through dossier development for clinical trial applications, marketing applications, amendments, post approval variations, and other regulatory submissions.
As a CMC Regulatory Sciences Specialist, a typical day might include the following:
• Preparing global CMC documents and sections for a variety of clinical and 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 stakeholders, including outside partners, informed of progress.
• Collaborating and developing excellent relationships with functional area and cross functional teams, contract manufacturing organizations, and global Regulatory partners.
• Working on a cross-functional team to ensure regulatory strategy is in alignment with drug supply plans.
• Appling in-depth understanding of regulatory guidance and regulations, as well as industry and government agency standard methodologies and trends.
• Reviewing relevant CMC documents and reports for completeness, accuracy and compliance with regulations and regulatory guidance.
• May coordinate and assign projects to specialists; may have direct reports.
This might be for you if you:
• Proactively identify issues and contribute to the development of appropriate strategies to mitigate risk.
• Wish to assist in preparation for meetings with global regulatory authorities.
• Look to contribute to developing CMC regulatory strategy.
• Have excellent written and verbal communication skills.
• Work independently, prioritize, coordinate, and complete multiple projects within deadline while maintaining a high level of attention to detail.
• Have knowledge of relevant drug development regulations and guidelines (i.e. FDA regulations and ICH guidelines) as well as an understanding of cGMPs (Current Good Manufacturing Practices).
• Possess strong skills in planning, critical thinking, and problem-solving.
To be considered for the CMC Regulatory Sciences Specialist role, you must have the following; BA/BS degree required, preferably in a scientific related field. Associate Specialist level aligns with 0-2 years of relevant experience, Specialist level 2+ years of relevant experience. At the Senior Specialist level an advanced degree is preferred with 4+ years of relevant experience or 5+ years of relevant experience with BA/BS. Level is determined based on qualifications relevant to the role.
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 amazing benefits including health and wellness programs, fitness centers and stock for 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 maternity 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.