Regulatory Affairs Lead
2 weeks ago
Regulatory Affairs Manager at Regeneron Pharmaceuticals, Inc.
Key Responsibilities- Lead proactive monitoring and surveillance on changes in the global regulatory landscape focused on drug development lifecycle starting from preclinical through commercialization.
- Manage comprehensive day-to-day oversight and operation of Reg Intel Systems and Dashboards to ensure seamless monitoring and analysis of regulatory trends and compliance requirements.
- Collaborate with cross-functional teams, including IT, GDS, compliance, regulatory affairs, and other functions as well as external vendors to ensure alignment of Reg Intel Systems and dashboards with organizational goals and regulatory requirements.
- Identify business-critical aspects and communicate effectively to internal stakeholders.
- Streamline Regulatory Intelligence-related processes and improve operational efficiency through collaboration with cross-functional teams.
- Provide ongoing support and training to users of the Reg Intel Systems and dashboards.
- Minimum Bachelor's Degree in Sciences, Engineering, or other similar discipline.
- Project Management/Six Sigma certification a plus.
- Minimum 5-6 years of experience in the biotech/pharmaceutical industry or Health Authority experience (with a focus in Regulatory, Drug Safety, and/or Clinical preferred).
- Strong analytical skills with the ability to interpret complex regulatory information and provide actionable insights.
- Excellent written and verbal communication skills, with the ability to effectively communicate complex regulatory information to diverse audiences.
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