Regulatory FSP Director – CMC Lead

🔥 0 minutes ago

🌐 Bulgaria, France, +3 more countries – Remote

🇧🇬 Bulgaria – Remote 🇫🇷 France – Remote 🇮🇹 Italy – Remote 🇧🇪 Belgium – Remote 🇬🇧 United Kingdom – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Lead, coach, and develop staff, including interviewing, professional development, goal setting, performance management, and mentoring • Approve or recommend salary administration, hiring, corrective action, and termination decisions • Review and approve time records, expense reports, leave requests, and overtime • 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 an 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 • Align team capabilities, work allocation, and delivery expectations with client requirements • 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, CMC scope, delivery needs, 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 and procedures that improve productivity, accuracy, and consistency • Contribute to systems and tools improving efficiency, submission activities, metrics, and key performance indicators

🎯 Requirements

• Bachelor’s degree or equivalent and relevant formal academic or vocational qualification • 12+ years of previous experience providing the knowledge, skills, and abilities to perform the job • 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 for clinical trial authorization, marketing authorization, and product lifecycle management • Superior understanding of ICH guidelines and relevant global regulatory guidance • Ability to provide practical CMC advice and recognize when escalation or additional expertise is needed • Ability to assess sponsor needs independently and produce compliant deliverables • Advanced understanding of budgeting and forecasting • Strong analytical, investigative, and detail-oriented skills • Ability to supervise, evaluate, mentor, and develop personnel; delegate work; and facilitate timely completion of assignments • Ability to provide functional oversight to FSP teams and manage changing priorities • Ability to translate client requirements into CMC scope, delivery, and resource considerations • Ability to drive innovation and improve processes, productivity, and service quality • Excellent organizational, judgment, analytical, decision-making, and interpersonal skills • 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 liaise effectively with other departments • Occasional travel may be required

🏖️ Benefits

• Potential occasional travel required • Professional development • Collaboration and development opportunities • Global team environment • Scientific excellence-focused workplace

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume