Regulatory FSP Director – CMC Lead

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

📋 Description

• Lead, mentor, and develop team members, encompassing interviewing, professional growth, goal setting, performance evaluation, and coaching.

• Approve or suggest decisions regarding salary administration, hiring, corrective actions, and terminations.

• Review and authorize time records, expense reports, leave requests, and overtime submissions.

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

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

• Provide technical expertise and coordination oversight specific to projects.

• Act as an executive point of contact for key clients regarding CMC-related issues.

• Support meetings with regulatory authorities and other public-facing engagements.

• Oversee functional management and support delivery for CMC FSP teams.

• Align team capabilities, work distribution, and delivery expectations with client requirements.

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

• Assist with resource planning and forecasting across CMC tasks.

• Manage project budgeting and forecasting and participate in project meetings.

• Identify activities beyond the project scope and support contract adjustments.

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

• Provide CMC expertise for presentations, proposals, bid texts, budgets, and contract negotiations.

• Evaluate potential projects, CMC scope, delivery requirements, feasibility, team structure, and resource needs.

• Contribute to both global and regional CMC functional strategies.

• Ensure adherence to organizational and departmental SOPs and WPDs.

• Develop and implement processes and procedures aimed at enhancing productivity, accuracy, and consistency.

• Contribute to systems and tools that enhance efficiency, submission activities, metrics, and key performance indicators.

⛳️ Requirements

• Bachelor’s degree or its equivalent, along with relevant formal academic or vocational qualifications.

• Over 12 years of relevant experience providing the necessary knowledge, skills, and abilities for the role.

• More than 5 years of management experience.

• Strong leadership capabilities.

• Excellent communication and negotiation skills in English, both oral and written.

• Proficiency in local languages where applicable.

• Advanced understanding of CMC regulatory affairs, including global, regional, and national requirements and procedures regarding clinical trial authorization, marketing authorization, and product lifecycle management.

• In-depth knowledge of ICH guidelines and relevant global regulatory guidance.

• Ability to offer practical CMC advice and recognize when escalation or additional expertise is necessary.

• Capability to independently assess sponsor needs and produce compliant deliverables.

• Advanced understanding of budgeting and forecasting.

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

• Ability to supervise, evaluate, mentor, and develop staff; delegate tasks; and ensure timely completion of assignments.

• Capacity to provide functional oversight to FSP teams while managing shifting priorities.

• Skill in translating client requirements into CMC scope, delivery, and resource considerations.

• Ability to drive innovation and enhance processes, productivity, and service quality.

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

• Ability to manage complex tasks simultaneously.

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

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

• Occasional travel may be required.

🏝️ Benefits

• Potential for occasional travel.

• Opportunities for professional development.

• Collaborative and developmental opportunities.

• Global team environment.

• Workplace focused on scientific excellence.