Regulatory FSP Director – CMC Lead

🔥 0 minutes ago

🌐 United Kingdom, Bulgaria, +3 more countries – Remote

🇬🇧 United Kingdom – Remote 🇧🇬 Bulgaria – Remote 🇫🇷 France – Remote 🇮🇹 Italy – Remote 🇧🇪 Belgium – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Lead, coach, and develop staff, including interviewing, selection, professional development, performance management, and mentoring • Provide CMC regulatory subject-matter expertise to internal and external clients • Advise clients on CMC regulatory strategy and product development across development, registration, and lifecycle management • Provide project-specific technical expertise and coordination oversight • Serve as executive contact for key clients on CMC-related matters • Support regulatory authority meetings and other public-facing engagements • Provide functional oversight and delivery support for CMC FSP teams • Monitor performance and address risks, quality concerns, and changing priorities • Support resource planning and forecasting across CMC work • Oversee project budgeting and forecasting and participate in project meetings • Identify out-of-scope activities and support contract modifications • Collaborate with business development and senior management to price and secure new CMC and FSP business • Contribute CMC expertise to presentations, proposals, bid text, budgets, and contract discussions • Assess prospective work, feasibility, team structure, and resourcing • Contribute to global and regional CMC functional plans • Ensure compliance with organizational and departmental SOPs and WPDs • Develop and implement processes, procedures, systems, and tools to improve productivity, accuracy, consistency, efficiency, and cycle time

🎯 Requirements

• Bachelor’s degree or equivalent and relevant formal academic or vocational qualification • Previous experience comparable to 12+ years • 5+ years of management responsibility • Strong leadership skills • Superior English-language communication and negotiation skills, oral and written • Local-language skills where applicable • Advanced knowledge of CMC regulatory affairs, including global, regional, and national requirements and procedures • Superior understanding of ICH guidelines and relevant global regulatory guidance • Advanced understanding of budgeting and forecasting • Strong analytical, investigative, and detail-oriented skills • Ability to supervise, evaluate, mentor, and develop departmental personnel • Ability to provide functional oversight to FSP teams and manage competing priorities • Ability to support business development and translate client requirements into CMC scope, delivery, and resource considerations • Excellent organizational, judgment, analytical, decision-making, and interpersonal skills • Effective computer skills, including Microsoft Word, Microsoft Excel, Adobe Acrobat, and related tools • Ability to learn new technologies independently and liaise effectively with other departments • Occasional travel may be required • Equivalency through a combination of appropriate education, training, and/or directly related experience may be considered

🏖️ Benefits

• Potential occasional travel required • Professional development opportunities • Collaboration and development as part of the everyday experience • Global team environment • Scientific excellence-focused work environment

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