CMC Regulatory Sciences Specialist - Distribution Compliance

Rensselaer, NY, United States
Mar 20, 2021
Required Education
Position Type
Full time
We are currently looking to fill a CMC Regulatory Sciences Specialist (Distribution Compliance) position. This position executes activities in support of the regulatory aspects of distribution compliance within the CMC Regulatory Sciences Department. We are looking for someone who can efficiently organize and review regulatory documentation and perform reviews to drive clinical and commercial product distribution.

In this role, a typical day might include the following:
• Supporting drug supply distribution compliance (beyond GMP compliance) with all aspects of global regulatory filings to ensure stable supply positioning
• Collaborating with various functions to support clinical and commercial regulatory release process and inventory review
• Participating in development and execution of procedures and systems for enhanced tracking of change controls and global regulatory submissions and approvals
• Developing and maintaining reporting tools to communicate regulatory distribution compliance status to the business
• Identifying project and resource challenges and build alternate strategies to improve efficiency and ensure process sustainability
• Potentially supervising and assigning projects to the other team members

This role might be for you if:
• You have strong written, verbal, and interpersonal communication skills
• You can work independently and coordinate multiple projects simultaneously
• You can confidently build beneficial work relationships with partners and other areas of the business

To be considered for this role, you must have a BA/BS preferably in a scientific field with 2+ years of relevant experience. Title level will be based on education, skills, and years of experience. Relevant experience may substitute educational requirements. We need someone who can positively support the team by improving processes through collaboration and attention to detail.

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.