Regulatory Analyst

Roles and Responsibilities :

• Develop and implement regulatory strategies to ensure compliance with FDA regulations, GMP guidelines, and other relevant laws.
• Collaborate with cross-functional teams to identify potential risks and develop mitigation plans for product launches.
• Prepare and submit required reports to regulatory authorities, including Annual Product Reviews (APRs) and Facility Inspection Readiness Assessments (FIRAs).
• Provide stakeholder engagement by communicating effectively with internal stakeholders on regulatory matters.

Job Requirements :

• 6-12 years of experience in Regulatory Affairs Analyst role or related field.
• Strong understanding of FDA regulations, GMP guidelines, and other relevant laws governing pharmaceutical industry.
• Experience preparing APRs, FIRAs, reporting requirements; ability to analyze complex data sets.