Senior Director overseeing Quality & Regulatory Strategy for innovative medical device company. Partnering with executives to drive compliance and operational excellence in a regulated environment.
About the role
- Regulatory Scientist at ICON supporting regulatory strategies for clinical development programmes. Collaborating with cross-functional teams to ensure regulatory compliance and alignment.
Responsibilities
- Contributing to regulatory strategy development for clinical programmes, including plans for health authority interactions and submissions.
- Preparing, reviewing, and coordinating regulatory documents such as clinical trial applications, briefing packages, and responses to health authority questions.
- Interpreting and applying relevant regulations, guidelines, and precedents to support compliant study design and execution.
- Collaborating with clinical, safety, CMC, and other cross-functional teams to ensure alignment of regulatory content and messaging.
- Monitoring changes in the regulatory environment and providing guidance on potential impact to programmes and submissions.
- Supporting regulatory interactions and meetings, including preparation of materials and documentation of outcomes.
Requirements
- Advanced degree in life sciences, pharmacy, or a related field, or equivalent scientific and regulatory experience.
- Experience in regulatory affairs, with experience of UK submissions, 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.
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.
Job title
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