Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Make an Impact at the Forefront of Innovation
The Director, Regulatory Affairs — CMC FSP provides senior technical and operational leadership for CMC regulatory services, with a focus on supporting Functional Service Provider (FSP) teams and clients. This role combines CMC subject-matter expertise with functional oversight, resource planning, business development support, and delivery leadership.
The Director serves as a senior CMC regulatory advisor for client requests, ad hoc assignments, and queries from other functions. The role partners with business development and senior leaders to shape and secure new work, assess resourcing needs, provide oversight to FSP teams, and help ensure high-quality, compliant delivery across client engagements.
What You’ll Do
- Lead, coach, and develop staff. Responsibilities may include interviewing and selection, preparing job descriptions, professional development, goal setting, performance management, behavioral and technical coaching and mentoring, employee counseling, and separations. Approve or recommend actions related to salary administration, hiring, corrective action, and termination. Review and approve time records, expense reports, leave requests, and overtime. Promote the company’s Equal Employment Opportunity policy and Affirmative Action Plan, and ensure adherence to ethical and regulatory standards.
- Provide CMC regulatory subject-matter expertise to internal and external clients. Respond to client requests, ad hoc assignments, and queries from other functions, providing clear, timely advice and identifying when additional expertise or escalation is needed.
- Advise clients on CMC regulatory strategy and product development considerations across relevant stages of development, registration, and lifecycle management. Provide project-specific technical expertise and coordination oversight, including for key client projects.
- Serve as an executive contact for key clients on CMC-related matters. Support client discussions, including regulatory authority meetings and other public-facing engagements, as appropriate. Promote quality performance across key and managed projects.
- Provide functional oversight and delivery support for CMC FSP teams. Help align team capabilities, work allocation, and delivery expectations with client requirements; monitor performance and address risks, quality concerns, or changing priorities in a timely manner.
- Support resource planning and forecasting across CMC work. Assess capability and capacity needs, recommend resource allocations, and help adjust staffing plans in response to changes in scope, workload, or client priorities.
- Oversee project budgeting and forecasting, including recommendations on resource shifts and allocations to address changes in scope or personnel requirements and maintain delivery within budget. Lead and participate in project meetings.
- Identify out-of-scope activities in a timely manner and partner with the relevant functions to assess the impact, communicate with the client, and progress contract modifications.
- Collaborate with business development and senior management to price and secure new CMC and FSP business. Contribute CMC expertise to client presentations, proposals, bid text, budgets, and contract discussions through closure. Actively pursue collaborative and standalone opportunities and support existing clients seeking additional services.
- Partner with business development, operations, and functional leaders to assess prospective work, clarify CMC scope and delivery needs, and inform decisions on feasibility, team structure, and resourcing.
- Contribute to the development and implementation of global and regional CMC functional plans.
- Ensure compliance with relevant organizational and departmental SOPs and WPDs, and promote consistent application across CMC FSP teams.
- Develop strategies and lead the development and implementation of processes and procedures that improve team productivity, accuracy, and consistency.
- Contribute to the development and implementation of systems and tools that improve efficiency across CMC activities. Support process improvement, cycle-time reduction, submission activities, metrics, and other key performance indicators.
Education & Experience Requirements
- Bachelor’s degree or equivalent and relevant formal academic or vocational qualification.
- Previous experience that provides the knowledge, skills, and abilities to perform the job, comparable to 12+ years.
- 5+ years of management responsibility.
- Strong leadership skills.
- In some cases, an equivalency consisting of a combination of appropriate education, training, and/or directly related experience may be considered sufficient to meet the requirements of the role.
Knowledge, Skills & Abilities
- Superior English-language communication and negotiation skills, both oral and written, and local-language skills where applicable.
- Advanced knowledge of CMC regulatory affairs, including relevant global, regional, and national requirements and procedures for clinical trial authorization, marketing authorization, and product lifecycle management.
- Superior understanding of ICH guidelines and other relevant global regulatory guidance, with the ability to apply CMC regulatory knowledge to client and project needs.
- Ability to provide practical CMC advice across a range of client requests, ad hoc assignments, and cross-functional queries, and to recognize when an issue requires escalation or additional expertise.
- Ability to assess sponsor needs independently and work with project team members to produce compliant deliverables.
- Advanced understanding of budgeting and forecasting, with strong analytical, investigative, and detail-oriented skills.
- Ability to supervise, evaluate, mentor, and develop departmental personnel; delegate work; and facilitate timely completion of assignments.
- Ability to provide functional oversight to FSP teams, balance competing priorities, and respond effectively to changing client and business needs.
- Ability to support business development by translating client requirements into clear CMC scope, delivery, and resource considerations.
- Ability to drive innovation and develop ideas that improve processes, productivity, and service quality.
- Excellent organizational, judgment, analytical, decision-making, and interpersonal skills, including the ability to manage complex work in parallel.
- Effective computer skills, including Microsoft Word, Microsoft Excel, Adobe Acrobat, and related tools.
- Ability to learn new technologies independently and act effectively as a liaison with other departments.
Working Conditions & Environment
- Work is performed in an office or clinical environment with exposure to electrical office equipment.
- Potential occasional travel required.
Why Join Us?
When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.
