FSP Regulatory Affairs Specialist – CMC Compliance Officer

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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

• Contribute to ensuring products meet global regulatory requirements • Work with cross-functional teams to manage product registrations, maintain compliance documentation, and support regulatory submissions across international markets • Compile technical documentation and review regulatory requirements • Support product lifecycle management from initial registration through post-market activities • Collaborate with Quality Assurance, R&D, Commercial teams, and regulatory authorities to ensure compliance • Facilitate efficient product launches and maintain existing approvals • Facilitate compliance activities within the TechOps team in collaboration with Product Quality and the External Manufacturing network • Ensure cross-functional alignment for critical compliance topics and projects • Maintain dashboards and keep compliance operations on track • Resolve potential issues affecting timely assessment and closure of actions • Maintain change-control trackers and coordinate implementation dates with CMOs • Facilitate cross-functional change-control meetings and ensure actions are completed on time • Coordinate with supply plans for impacted post-change batches and align multi-asset changes per site • Manage the Change Control Review Board • Establish and maintain deviation trackers and pursue critical deviation actions with CMOs • Build an adequate deviation-management system in partnership with Quality • Extract applicable change controls for annual reports and facilitate annual-report drafting and review • Maintain health-authority commitment trackers and coordinate timelines, actions, and technical activities • Ensure studies are initiated on time to generate submission data • Track execution of regulatory commitments with the Regulatory CMC team • Coordinate excipient material and supplier choices to comply with regional pharmacopoeia requirements and compendial updates • Prepare regular compliance dashboards

🎯 Requirements

• Degree in biotechnology, pharmaceutical sciences, or bioengineering • Relevant expertise in CMC Project Management, Quality & Compliance, or a similar biotech-industry role • Additional qualifications in Quality Management or Regulatory Affairs advantageous • Knowledge of medical device and IVD regulations, including EU MDR/IVDR, FDA, and international requirements • Experience with regulatory submissions and documentation management • Strong technical writing and documentation skills • Proficiency in Microsoft Office applications, including Word, Excel, and PowerPoint • Experience with document management systems preferred • Excellent organizational abilities and attention to detail • Strong analytical and problem-solving capabilities • Effective verbal and written communication skills in English • Ability to work independently and collaboratively in a matrix environment • Experience with regulatory databases and submission systems preferred • Knowledge of GMP, ISO 13485, and quality management systems • Ability to manage multiple projects and meet deadlines • Strong interpersonal and customer-focused skills • Ability to build effective relationships with internal and external stakeholders • Leadership and communication skills • Experience in operations, planning, project management, and tracking highly complex, high-risk projects with clearly defined critical paths • Experience managing projects across global locations and time zones and working effectively in diverse cultural and international environments • Ability to handle multiple assignments in parallel • Detail-oriented and quality-conscious attitude • Proactive, can-do mentality

🏖️ Benefits

• Excellent professional development opportunities • Reasonable accommodation for individuals with disabilities during the application, interview, and employment process • Equal employment opportunity without regard to protected characteristics