Senior Regulatory CMC Strategy Manager

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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 for defining global regulatory CMC strategies and objectives pertaining to the development, registration, commercialization and lifecycle management of the drug product in the United States and international markets • Liaising directly with the US FDA and with local regulatory teams for discussions with international health authorities and agencies for CMC-related matters • 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 (e.g., BLAs, INDs, CTAs, MAAs, Variations/Supplements and other relevant regulatory filings such as meeting requests and briefing packages) for the assigned product(s) within defined timelines as per R&D and business objectives • Advising on regulatory strategies, solutions to scientific problems and interpretation of results in the context of product registration requirements combined with business needs and goals • Facilitating the communication and flow of regulatory information (regulatory framework, scope and project timelines) to all relevant stakeholders • Identifying and recommending the most effective CMC regulatory strategies to assure a first-pass regulatory approval of initial application and lifecycle supplements/variations • Collaborating with key functions in the preparation, review and approval of regulatory CMC submissions as assigned to product and programs • In collaboration with the network strategist, developing and managing timelines supporting regulatory submissions, proactively identifying risks and developing adequate risk management solutions in consultation with cross-functional teams

🎯 Requirements

• Bachelor's degree in a relevant scientific discipline or healthcare-related field • Extensive experience in global pharmaceutical/biotechnological drug development and proven knowledge of the global regulatory CMC environment • Demonstrated experience in authoring and managing components of regulatory submissions • Good knowledge of global regulatory requirements and demonstrated ability to function as the lead interface with FDA • Ability to support regional and local regulatory affairs teams for interactions with regional or local health authorities (e.g., EMA, PEI, AGES, PMDA, Health Canada, etc.) • Demonstrated ability to develop and implement global CMC regulatory strategies, resolve complex issues, and negotiate optimal regulatory pathways and outcomes with health authorities.

🏖️ Benefits

• Competitive base salary and performance related incentives • Health and wellbeing programmes including medical, dental, and vision coverage where applicable • Retirement and pension plans • Life assurance and disability coverage • Employee assistance programmes and wellbeing resources • Learning and development opportunities through structured training and career pathways