Associate Manager - Product Quality Review (CMC Regulatory Sciences)

Rensselaer, NY, United States
May 22, 2021
Required Education
Bachelors Degree
Position Type
Full time
We are hiring for an Associate Manager - Product Quality Review to oversee the gathering and interpretation of 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 Associate Manager - Product Quality Review, a typical day might include the following:
• Supporting the oversight and assignment of projects/work to the Product Quality Review team
• Collaborating cross-functionally in the preparation and review of PQRs, providing feedback on format, content, and guidance in general
• Developing streamlined methods to capture needed information to prepare finished PQRs, focusing on efficiency and compliance
• Collaborating with manufacturing and quality personnel in monitoring the manufacturing process as well as preparing and reviewing documents
• Supporting and acting as a subject-matter-expert during regulatory inspections and partner audits
• Identifying and driving any opportunities to reduce potential regulatory compliance risks across all areas evaluated within the scope of the PQR
• Assessing quality-related information to detect trends and working with Subject Matter Experts to determine the need for actions required in response to those trends
• Communicating PQR data to senior management, regulatory agencies, and business partners and corresponding with global business partners and contract manufacturing organizations
• Applying a versatile understanding of regulatory guidance and regulations
• 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 issues and contributing in the development of alternate strategies
• Potentially supervising and assigning projects to specialists
• Continually evaluating processes and procedures with a drive towards continuous improvement

This role might be for you if:
• You have strong written and verbal communication skills
• You proactively identify issues and aide in the development or appropriate strategies to mitigate risk
• 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 role you must have a BS/BA and 6+ year of relevant experience, or equivalent combination of education and experience. A degree in a scientific field is preferred. We are looking for someone who has experience in creating databases and organizing/visualizing data and has quality assurance, quality auditing, quality systems, quality control, or pharmaceutical manufacturing related 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.