Regulatory Affairs Manager specializing in food industry compliance across US/North America. Leading regulatory strategies and communication for food ingredients and products.
About the role
- Senior Global Regulatory Scientist at ICON supporting regulatory strategies for clinical development programmes. Collaborating with cross-functional teams to ensure compliant study designs and submissions.
Responsibilities
- 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.
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
Compliance Analyst participating in financial compliance processes at Prex. Utilizing data analysis for risk identification and maintaining regulatory compliance.
Control, Risk and Compliance Analyst at Desjardins managing compliance for savings and investment products. Preparing reports and liaising with stakeholders to ensure regulatory compliance and operational risk management.
Senior Manager leading technology - enabled GRC solutions and guiding compliance frameworks. Collaborates with teams to ensure scalable and practical implementations for Crowe's regulatory practices.
Alternant en conformité réglementaire chez Sanofi, contribuant à la conformité mondiale des activités de santé. Collaborant avec une équipe pour développer compétences tout en soutenant l'avenir de la santé.
Environmental Professional ensuring air compliance and permit management for oil and gas operations. Collaborating with teams on compliance, reporting, and regulatory issues across various states.
Senior Audit & Compliance Specialist developing audit schedules and conducting audits in insurance sectors. Collaborating with teams to drive quality improvements across claims procedures and training.
Senior Manager overseeing quality compliance and implementation of Quality Systems in external manufacturing. Supporting compliance with regulatory standards across Global External Manufacturing network at Bristol Myers Squibb.
Analyst supporting energy efficiency programs at Eversource. Reporting operations, regulatory support, and portfolio forecasting for clean energy initiatives in Massachusetts.
Technology Compliance Officer at Specsavers ensuring regulatory compliance across Northern Europe. Guiding product teams in understanding obligations while building compliance into design and process.