Regulatory FSP Director – CMC Lead

This is a fully remote position, open to applicants in United Kingdom, +4 more countries.

📋 Description

• Lead, mentor, and develop team members, which includes interviewing, selecting, managing performance, and providing professional development.

• Offer CMC regulatory expertise to both internal and external clients.

• Guide clients on CMC regulatory strategies and product development throughout the phases of development, registration, and lifecycle management.

• Deliver project-specific technical expertise and oversee coordination efforts.

• Act as the primary executive contact for key clients regarding CMC-related matters.

• Assist in regulatory authority meetings and other public engagements.

• Provide functional oversight and delivery support for CMC FSP teams.

• Monitor team performance, addressing risks, quality issues, and shifting priorities.

• Aid in resource planning and forecasting across CMC projects.

• Oversee project budgeting and forecasting while participating in project meetings.

• Identify activities outside the scope and assist with contract modifications.

• Work collaboratively with business development and senior management to price and secure new CMC and FSP business opportunities.

• Contribute CMC knowledge to presentations, proposals, bid texts, budgets, and contract negotiations.

• Evaluate potential work, feasibility, team structure, and resourcing needs.

• Contribute to the formulation of global and regional CMC functional plans.

• Ensure adherence to organizational and departmental SOPs and WPDs.

• Develop and implement processes, procedures, systems, and tools aimed at enhancing productivity, accuracy, consistency, efficiency, and cycle time.

⛳️ Requirements

• Bachelor’s degree or equivalent relevant academic or vocational qualification.

• At least 12 years of comparable prior experience.

• A minimum of 5 years in a management role.

• Strong leadership capabilities.

• Exceptional English-language communication and negotiation skills, both oral and written.

• Proficiency in local languages where applicable.

• In-depth knowledge of CMC regulatory affairs, including global, regional, and national standards and procedures.

• Comprehensive understanding of ICH guidelines and pertinent global regulatory guidance.

• Advanced skills in budgeting and forecasting.

• Strong analytical, investigative, and detail-oriented abilities.

• Capability to supervise, assess, mentor, and develop departmental staff.

• Ability to provide functional oversight to FSP teams while managing competing priorities.

• Competence in supporting business development and converting client requirements into CMC scope, delivery, and resource considerations.

• Excellent organizational, judgment, analytical, decision-making, and interpersonal abilities.

• Proficient computer skills, including Microsoft Word, Microsoft Excel, Adobe Acrobat, and related tools.

• Ability to independently learn new technologies and effectively interact with other departments.

• Occasional travel may be necessary.

• Equivalency through a combination of relevant education, training, and/or directly related experience may be considered.

🏝️ Benefits

• Potential for occasional travel required.

• Opportunities for professional development.

• Collaboration and development as integral parts of daily experiences.

• Work within a global team environment.

• Focused on scientific excellence in the work environment.