Regulatory Consultant managing the review of applications and issuance of licenses for alcoholic beverages and tobacco in Florida. Ensuring compliance and assisting businesses with licensing laws.
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
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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