Regulatory Compliance Specialist
In this pivotal role, you will ensure Regeneron's Data Governance systems and practices meet the highest standards of regulatory compliance.
Key Responsibilities:
* Assess current and evolving regulatory guidance to inform business practices.
* Develop and author standards, policies, and procedures aligned with regulatory requirements.
* Conduct technical writing, research, and editing to ensure accuracy and consistency of documentation.
* Perform data mapping processes, risk assessments, and criticality evaluations.
* Identify data governance gaps and propose solutions with implementation plans.
* Lead data integrity remediation activities and promote a culture of quality and governance within the organization.
* Drive communication and collaboration between stakeholders to ensure effective DG practices.
* Encourage continuous improvement by actively seeking feedback and supporting initiatives to enhance data quality and governance.
Requirements:
* Knowledge of applicable federal, state, and local regulations, such as FDA Guidance on Data Integrity and GDPR.
* Technical writing experience and understanding of workflows and quality management terminology.
* Ability to collaborate with cross-functional teams and communicate complex regulatory and technical requirements.
* Strong stakeholder management and influencing skills.
* Experience developing global policies, procedures, and standards in regulated work areas.
Qualifications:
* BA/BS degree or equivalent combination of education and experience in pharmaceutical/FDA regulated work areas.
* 7+ years of professional experience in data management & operations, quality assurance, compliance, manufacturing operations, quality control, or IT.