FSP Regulatory Affairs Specialist – CMC Compliance Officer

This is a fully remote position, open to applicants in Belgium.

📋 Description

• Assist in ensuring that products comply with global regulatory standards.

• Collaborate with cross-functional teams to oversee product registrations, maintain compliance documentation, and aid in regulatory submissions across international markets.

• Compile technical documentation and evaluate regulatory requirements.

• Support product lifecycle management from initial registration to post-market activities.

• Partner with Quality Assurance, R&D, Commercial teams, and regulatory authorities to ensure compliance.

• Streamline product launches and uphold existing approvals.

• Coordinate compliance activities within the TechOps team in conjunction with Product Quality and the External Manufacturing network.

• Ensure alignment across functions for critical compliance topics and initiatives.

• Maintain dashboards and keep compliance operations on schedule.

• Address potential issues that may delay assessment and resolution of actions.

• Keep change-control trackers updated and coordinate implementation dates with Contract Manufacturing Organizations (CMOs).

• Organize cross-functional change-control meetings and ensure timely completion of actions.

• Work with supply plans for post-change batches and align multi-asset changes by site.

• Oversee the Change Control Review Board.

• Create and sustain deviation trackers and drive critical deviation actions with CMOs.

• Develop a robust deviation-management system in collaboration with Quality.

• Extract relevant change controls for annual reports and assist in their drafting and review.

• Maintain health-authority commitment trackers and manage timelines, actions, and technical tasks.

• Ensure timely initiation of studies to generate submission data.

• Monitor execution of regulatory commitments with the Regulatory CMC team.

• Coordinate choices of excipient materials and suppliers to meet regional pharmacopoeia requirements and compendial updates.

• Prepare regular compliance dashboards.

⛳️ Requirements

• Bachelor's degree in biotechnology, pharmaceutical sciences, or bioengineering.

• Relevant experience in CMC Project Management, Quality & Compliance, or a comparable role in the biotech industry.

• Additional qualifications in Quality Management or Regulatory Affairs are beneficial.

• Familiarity with medical device and IVD regulations, including EU MDR/IVDR, FDA, and international standards.

• Experience in regulatory submissions and management of documentation.

• Strong technical writing and documentation proficiency.

• Proficiency in Microsoft Office applications, including Word, Excel, and PowerPoint.

• Experience with document management systems is preferred.

• Exceptional organizational skills and meticulous attention to detail.

• Strong analytical and problem-solving abilities.

• 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 is advantageous.

• Knowledge of GMP, ISO 13485, and quality management systems.

• Capacity to manage multiple projects and meet deadlines.

• Strong interpersonal skills and a customer-oriented attitude.

• Ability to cultivate effective relationships with both internal and external stakeholders.

• Leadership and communication skills.

• Experience in operations, planning, project management, and tracking complex, high-risk projects with clearly defined critical paths.

• Experience managing projects across global locations and time zones, effectively working in diverse cultural and international contexts.

• Capability to handle multiple assignments simultaneously.

• Detail-oriented and quality-focused mindset.

• Proactive and positive attitude.

🏝️ Benefits

• Excellent opportunities for professional development.

• Reasonable accommodations for individuals with disabilities throughout the application, interview, and employment process.

• Equal employment opportunity regardless of protected characteristics.