Job Title:
Regulatory Compliance Professional
As a Regulatory Compliance Professional, you will be responsible for supporting the planning and execution of compliance initiatives using the sourcing process for raw material manufacturers and distributors. You will maintain all cGMP compliance aspects of Global Procurement operations under the direction and mentorship of Sourcing Management.
Key Responsibilities:
1. Supporting and proactively maintaining all Sourcing cGMP procedures, documentation and training related to SOP and Work Instructions
2. Maintaining the Approved Supplier List (ASL)
3. Coordinating compliance needs and collaborates with other sites to ensure engagement, feedback and consensus related to Global Procurement document revisions
4. Driving successful audit closures by focusing on proactive issue resolutions and communication with suppliers to effect acceptable audit closures for raw materials
5. Coordinating with Cross-Functional Compliance resources to support Global Procurement and Quality Auditing needs for acceptable closure of audit findings and to secure evidence that substantiates supplier commitments
6. Assisting with the management of Supplier Corrective Action Reports (SCARs)
7. Completing change controls to ensure they are done accurately and effectively
8. Working with the global team to review and drive timely closure of NOE / deviations and associated processes (CAPA) Actions the Global Procurement responses to compliance related requests for data from Regulatory, Quality Assurance, Audit staff and other stakeholders
Required Skills and Qualifications:
* A proven understanding of quality and compliance electronic tools/ systems and experience supporting cross-functional teams to get results in SCARs, ASLs, CAPAs, Change Notifications, and related Quality and Compliance processes
* Experience operating with integrity, focus, and transparency in an environment of ambiguity to motivate change and improvement
* A continuous improvement attitude in identifying areas of improvements and working with leadership to implement them
* The ability to build positive relationships with partners and suppliers
Benefits:
We have an inclusive culture that provides comprehensive benefits which vary by location. In the U.S., benefits may include health and wellness programs, fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves for eligible employees at all levels.
Others:
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 parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.