Senior Global Regulatory Scientist

Role Overview

• Support the development, implementation, and execution of regulatory strategies for clinical development programmes.
• Take responsibility for regulatory affairs deliverables, applying 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.

Requirements

• Bachelor's degree in a relevant scientific discipline or healthcare-related field
• Experience in regulatory affairs, regulatory writing, or clinical development within the pharma, biotech, or CRO industry.
• Good understanding of global regulatory frameworks and guidelines relevant to clinical development.
• Strong scientific, analytical, and critical thinking skills, with the ability to interpret complex data and regulations.
• Excellent written and verbal communication skills, with high attention to detail and accuracy.
• Ability to work effectively in cross-functional teams and manage multiple regulatory activities and timelines.
• Willingness to travel as required (approximately 5%)

Benefits

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.