Regulatory CMC Strategy Manager

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🕒 May 18

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ICON plc

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1990

💊 Pharmaceuticals

🧬 Biotechnology

⚕️ Healthcare Insurance

Pharmaceuticals • Biotechnology • Healthcare Insurance

ICON plc is a global provider of clinical, consulting, and commercial services across various sectors in the healthcare and pharmaceutical industries. They offer a wide range of clinical solutions, including decentralised clinical trials, cardiac safety solutions, early clinical laboratories, and medical imaging. ICON also provides technology solutions that support drug development from early phases to post-marketing. Their therapeutic expertise spans cardiovascular, oncology, internal medicine, and more, with a strong focus on transformative therapies like cell and gene therapies and biosimilars. ICON is recognized as a leading Contract Research Organisation (CRO), regularly providing thought leadership and contributing to industry publications and events. Their services are tailored to optimize clinical trials, offer regulatory intelligence, and deliver real-world evidence through robust data analysis and patient-centric solutions.

📋 Description

• Defining, coordinating and implementing global CMC regulatory strategies for product specific development and life-cycle activities • Providing proactive strategic guidance to the product-specific global regulatory and manufacturing sub-teams • Liaising directly with the US FDA and with local regulatory teams for discussions with international health authorities • Negotiating with regulatory authorities during the development process to ensure submission acceptance and approval • Managing the CMC regulatory strategy of high quality and compliant regulatory CMC documentation • Advising on regulatory strategies and solutions to scientific problems • Facilitating the communication and flow of regulatory information to all relevant stakeholders • Identifying and recommending the most effective CMC regulatory strategies

🎯 Requirements

• Bachelor's degree in a relevant scientific discipline or healthcare-related field • Extensive experience in global pharmaceutical/biotechnological drug development • Proven knowledge of the global regulatory CMC environment • Demonstrated experience in authoring and managing components of regulatory submissions • Good knowledge of global regulatory requirements • Ability to function as the lead interface with FDA • Ability to support regional and local regulatory affairs teams • Demonstrated ability to develop and implement global CMC regulatory strategies • Resolve complex issues and negotiate optimal regulatory pathways and outcomes with health authorities.

🏖️ 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.