Compliance

• Take responsibility for regulatory affairs deliverables, applying your skills to ensure quality and efficiency.
• Contribute to regulatory strategy development for clinical programmes, including plans for health authority interactions and submissions.
• Prepare, review, and coordinate regulatory documents such as clinical trial applications, briefing packages, and responses to health authority questions.
• Interpret and apply relevant regulations, guidelines, and precedents to support compliant study design and execution.
• Collaborate with clinical, safety, CMC, and other cross-functional teams to ensure alignment of regulatory content and messaging.
• Monitor changes in the regulatory environment and provide guidance on potential impact to programmes and submissions.
• Support regulatory interactions and meetings, including preparation of materials and documentation of outcomes.

Senior Global Regulatory Scientist

• Participate in A-LIGN’s management system as it relates to information security standards (including, but not limited to, SOC 2, ISO 27001, NIST 800-53, NIST 800-171)
• Manage the annual audit calendar.
• Coordinate annual audit activities with both external and internal stakeholders.
• Participate in internal and external audit activities.
• Review and track identified non-conformities and opportunities for improvement resulting from audits.
• Prepare regular compliance reports.
• Review, update, and manage documentation in line with information security standards and corporate objectives.
• Complete third-party questionnaires from clients
• Support the vendor management process.
• Participate in business continuity and disaster recovery planning and test execution.

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Senior Global Regulatory Scientist

GRC Analyst