FSP Regulatory Affairs Specialist – CMC Compliance Officer

• 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 monitor completion of change actions
• Coordinate with Supply Planning for impacted post-change batches
• Align multi-asset changes per site with Quality
• Manage the Change Control Review Board
• Establish and maintain deviation trackers and pursue critical deviation actions with CMOs
• Build a system for adequate deviation management in partnership with Quality
• Extract applicable change controls for annual reports by asset and jurisdiction
• Facilitate cross-functional annual report drafting and review
• Maintain health authority commitment trackers and timelines per asset
• Coordinate actions and technical activities to initiate studies in time for submission data generation
• Track execution of regulatory commitments with the Reg CMC team
• Coordinate excipient material and supplier choices to meet regional pharmacopoeia requirements and compendial updates
• Prepare regular compliance dashboards
• Compile technical documentation, review regulatory requirements, support regulatory submissions, and contribute to product lifecycle management

• Degree in biotechnology, pharmaceutical sciences or bioengineering
• Relevant expertise in CMC Project Management or Quality & Compliance background, or a similar role within the Biotech industry
• Knowledge of medical device and IVD regulations (EU MDR/IVDR, FDA, international requirements)
• Experience with regulatory submissions and documentation management
• Strong technical writing and documentation skills
• Proficiency in Microsoft Office applications (Word, Excel, PowerPoint) and preferably with document management systems
• Excellent organizational abilities and attention to detail
• Strong analytical and problem-solving capabilities
• Effective verbal and written communication skills in English
• Ability to work both 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
• Customer-focused mindset with strong interpersonal skills
• Demonstrates company values of Integrity, Intensity, Innovation, and Involvement
• Team player; able to build effective relationships with internal and external stakeholders
• Leadership and communication skills
• Experience in operations, planning, project management, and tracking projects with high complexity and risk, including clearly defined critical paths
• Experience managing projects across global locations and time zones, as well as working effectively in diverse cultural and international environments
• Well organized and able to handle multiple assignments in parallel
• Eye for detail and quality conscious attitude
• Proactive – can do mentality

• Fully remote work arrangement
• Professional development opportunities
• Resources to support individual career goals