The CMC Regulatory Sciences Specialist gathers and interprets data associated with the preparation of product quality reviews (PQR). We are looking for someone to effectively drive the information outlined in procedures, regulations, and guidance documents for the preparation of product quality reviews and other documents.
As the CMC Regulatory Sciences Specialist, a typical day might include the following:
Reviewing manufacturing data to conduct timely product quality reviews while assessing quality-related information to detect trends
Collaborating with manufacturing and quality personnel in monitoring the manufacturing process as well as preparing and reviewing documents
Updating various sources of information into a uniform style and language for regulatory compliance
Communicating PQR data to senior management, regulatory agencies, and business partners and corresponding with global business partners and contract manufacturing organization
Supporting other teams in CMC Regulatory Sciences department with the preparation of regulatory documents to support all phases of drug development
Identifying project or resource constraints and chips into the development of alternate strategies
Potentially supervising and assigning projects to other specialists
This role might be for you if:
You have strong written and verbal communication skills
You can work independently, prioritize, coordinate and complete multiple projects while maintaining a high level of attention to detail
You are passionate about drug development and Regeneron's mission, including The Regeneron Way
To be considered for the Associate Specialist role you must have a BS/BA of equivalent combination of education and experience. For the Specialist role, you must have a BS/BA with 2 years of relevant experience or 5 years of experience as a Senior Specialist. A degree in a scientific field is preferred. We want someone who is proficient in creating databases and organizing/visualizing data as well as quality assurance, regulatory, or biopharma manufacturing experience. Experience with pharmaceutical quality systems is highly desirable.