FSP RA – Client Dedicated – CMC Project Manager

• Support Chemistry, Manufacturing and Controls (CMC) development for therapeutic antibodies
• Plan, control, monitor, and report assigned projects with CMC leads and project teams
• Manage CMC activities including process development, analytical development, product development, technical transfer, dossier development, clinical manufacturing, and project strategy
• Provide technical and project leadership for client projects
• Provide regulatory affairs expertise, client interface, strategic regulatory intelligence, and guidance from preclinical development through registration and product optimization
• Prepare strategic, efficient client deliverables meeting local, regional, and ICH requirements
• Liaise with internal and external clients
• Achieve project timelines, budget, and scope goals
• Translate scientific strategy into CMC project plans, visualize timelines and dependencies, and define budget needs
• Track, monitor, and report milestones and decision points
• Build relationships with stakeholders and monitor CMC activity progress
• Perform critical-path analysis, risk assessment, and scenario simulations
• Coordinate critical-path delivery, prioritize activities, and mitigate or escalate risks
• Prepare and lead project team meetings, agendas, action items, and minutes
• Promote collaboration, execution excellence, communication, and cross-functional problem-solving
• Review and advise on regional regulatory submissions
• Act as a regulatory strategy and technical subject-matter expert
• Ensure quality performance and compliance with SOPs and WPDs
• Manage project budgeting and forecasting
• Identify out-of-scope contract activities and coordinate contract modifications
• Collaborate with business development on pricing, proposals, presentations, and new business
• Provide matrix/project leadership, training, and guidance to junior team members
• Participate in launch, review, and project team meetings

• Master degree in life-sciences
• Previous experience comparable to 9+ years
• At minimum 5 years CMC project experience
• Experience working with biologics is a plus
• Excellent planning and organizational skills; ability to multitask and prioritize in a multicultural environment
• Strong analytical, problem-solving, and critical-thinking skills
• Experience working with CMC teams and managing relationships with CMC vendors is strongly preferred
• Ability to work in a dynamic, fast-growing biotech environment with challenging timelines
• Quality-conscious attitude
• Demonstrated project management skills and responsiveness to issues
• Excellent communication skills
• Ability to work in a fast-paced environment and adapt quickly to changing needs and priorities
• Fluent in English
• Excellent written and oral English communication skills, plus local language where applicable
• Excellent attention to detail, quality, and editorial/proofreading skills
• Exceptional interpersonal and liaison skills
• Advanced computer skills, including Microsoft Word, Excel, and PowerPoint
• Strong organizational, time-management, and planning skills
• Excellent negotiation skills
• Ability to work independently and exercise independent judgment
• Excellent understanding of global, regional, and national regulatory requirements and regulatory affairs procedures
• Expert knowledge of ICH and other global regulatory guidelines
• Advanced understanding of regulatory specialty areas such as preclinical, clinical, CMC, and publishing
• Superb understanding of medical terminology, statistical concepts, and guidelines
• Excellent analytical, investigative, and problem-solving skills
• Excellent understanding of budgeting and forecasting
• In some cases, an equivalency combining appropriate education, training, and/or directly related experience may be considered sufficient

• Fully remote work arrangement
• Standard Monday–Friday work schedule
• Occasional domestic and international travel
• Professional development through training and guidance to junior team members