Regulatory FSP Director CMC Lead - EMEA

Thermo Fisher Scientific5 LocationsonsiteSalary not postedView the original posting at Thermo Fisher Scientific ↗

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

The people who work here are one introduction away.

We show you who they are and write your first message — the insider list for this posting is filling in now. You have one introduction. The rest follows.

People at Thermo Fisher Scientific you can reach out to

45 of 73 public LinkedIn profiles found in searches for Thermo Fisher Scientific list Thermo Fisher Scientific in their headline — those are the ones you can be confident work there. Pick who to reach out to — we'll draft your message; you make the contact. The rest, when shown, are marked Unverified.

Profiles are public pages as indexed by the search engine — we never log in to LinkedIn or copy private data, and anyone can ask to be removed. Ask to be removed →

Start the conversation More Study start-up jobs