ICON plc
ICON plc is a leading Contract Research Organization (CRO) providing comprehensive clinical development services and solutions to the pharmaceutical, biotechnology, and medical device industries. With a focus on delivering high-quality, efficient clinical trial services, ICON supports clients at every stage of the development process, from early-phase trials through to post-marketing studies. ICON's expertise encompasses a range of therapeutic areas and includes innovative technologies to enhance patient centricity and streamline recruitment.
Medical Device • Therapeutics • Government and Public Health Solutions • Clinical Research Services • Commercialisation and Outcomes
Manager - Regulatory CMC
June 19
ICON plc
ICON plc is a leading Contract Research Organization (CRO) providing comprehensive clinical development services and solutions to the pharmaceutical, biotechnology, and medical device industries. With a focus on delivering high-quality, efficient clinical trial services, ICON supports clients at every stage of the development process, from early-phase trials through to post-marketing studies. ICON's expertise encompasses a range of therapeutic areas and includes innovative technologies to enhance patient centricity and streamline recruitment.
Medical Device • Therapeutics • Government and Public Health Solutions • Clinical Research Services • Commercialisation and Outcomes
📋 Description
• Plan, execute and manage regulatory submissions for assigned compounds or projects with appropriate supervision from RA CMC Management. • Define CMC content (data and documentation) requirements for regulatory submissions and review this content for conformance with established requirements. • Successfully communicate and negotiate with international subsidiaries and Health Authorities. • Prepare meetings with Health Authorities and represent Regulatory Affairs CMC as necessary. • Ensure project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. • Collaborate with manufacturing sites to successfully compile required documentation. • Interact with other internal and external colleagues, as well as with other functional areas and Alliance Partners. • Evaluate change proposals for regulatory impact and filing requirements. • Manage responses to letters of objections from Health Authorities for marketing authorization applications, product variations and renewals of international medicinal products.
🎯 Requirements
• Previous experience working in regulatory CMC and compiling Module 3 documentation in a pharmaceutical environment • A relevant educational background (preferably as a Chemist, Pharmacist or Biologist) • The ability to understand, apply, and articulate regulatory CMC requirements for global drug development and post-market support initiatives, and assess the impact of change requests against regulatory guidelines • Problem-solving ability, flexibility and team player • Fluency in written and spoken English
🏖️ Benefits
• Various annual leave entitlements • A range of health insurance offerings to suit you and your family’s needs • Competitive retirement planning offerings to maximise 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
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