Temp - Regulatory Affairs CMC Specialist

Performs activities in support of the CMC regulatory aspects of CTAs to support regulatory release and QP certification.

In this role, a typical day might include the following:

• Performs CMC regulatory alignment checks on CTA packages from CROs
• Building and maintaining tracking and reporting tools used to support CMC alignment review
• Coordinates the receipt of deliverables from cross-functional areas in a timely manner
• Keeps management and other cross-functional stakeholders informed on the status of deliverables
• Performs activities supporting global regulatory filings to ensure stable supply positioning, as time allows

This role might be for you if:

• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook)
• Working knowledge of Microsoft SharePoint
• Strong written, verbal and interpersonal communication skills and the ability to effectively interact cross-functionally
• Familiarity with pharmaceutical regulatory submissions and knowledge of FDA and international agency regulations
• Strong attention to detail and organizational skills
• Ability to organize and maintain accurate data or information
• Ability to learn and utilize computerized systems for daily performance of tasks
• Ability to prioritize, manage multiple tasks, and meet deadlines
• Requires a minimum of an bachelor’s degree (scientific discipline preferred) with 0-2 years of industry/relevant experience or equivalent combination of education and experience.

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.