Regulatory FSP Director – CMC Lead
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Job Description
CMC regulatory director leading Thermo Fisher Scientific’s EMEA FSP teams, client strategy, resourcing, and delivery. Supporting business development, compliance, budgeting, and process improvement.
Responsibilities:
- 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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