Regulatory Business Analyst

Job Summary

We are seeking a detail-oriented and analytical Regulatory Business Analyst. The ideal candidate will ensure that business processes comply with regulatory requirements and industry standards. This role involves analyzing regulatory changes, assessing their impact on the organization, and developing strategies to ensure compliance.

Primary Responsibilities

• Analyze and interpret regulatory requirements and guidelines to ensure compliance.
• Assess the impact of regulatory changes on business processes and operations.
• Develop and implement strategies to address regulatory requirements.
• Collaborate with cross-functional teams to ensure regulatory compliance across the organization.
• Prepare and submit regulatory reports and documentation.
• Monitor and report on compliance activities and performance metrics.
• Conduct risk assessments and develop mitigation plans.
• Provide training and support to staff on regulatory compliance matters.
• Stay up-to-date with changes in regulations and industry best practices.

Education and Experience

• Bachelor’s degree in Business Administration, Regulatory Affairs, or a related field.
• Minimum of 5 years of experience in regulatory analysis or compliance.
• Minimum of 5 years experience supporting Life Sciences projects.
• GxP experience required.
• Strong understanding of regulatory requirements and guidelines.
• Excellent analytical and problem-solving skills.
• Strong communication and interpersonal skills.
• Ability to work collaboratively with cross-functional teams.
• Proficiency in regulatory compliance software and tools.
• Attention to detail and ability to manage multiple projects simultaneously.
• Ability to work collaboratively with the team and independently as needed.
• Ability to prioritize and work closely with the Project Manager to ensure timely project completion.
• Ability to work on validation deliverables for multiple operational CCs and sprints simultaneously.
• Ability to understand cross-initiative dependencies.
• Ability to leverage key tools such as (MS Office, Jira, Lucid chart, and others like RAID log – crucial) required.
• Agile experience is a plus but not required.
• Veeva experience is a plus.