FSP Regulatory Affairs Specialist

pbWork Schedule /b /pStandard (Mon-Fri)pbEnvironmental Conditions /b /pOfficepbuJob Description /u /b /ppAs part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.brPlease make sure you read the following details carefully before making any applications.brDESCRIPTION:brJoin our collaborative team as a Regulatory Affairs Specialist I at Thermo Fisher Scientific, where you'll contribute to ensuring our products meet global regulatory requirements and help make the world healthier, cleaner, and safer. You'll work with cross-functional teams to manage product registrations, maintain compliance documentation, and support regulatory submissions across international markets. This position offers excellent professional development opportunities within our innovative environment focused on serving science.brAs a valuable member of our Regulatory Affairs team, you'll compile technical documentation, review regulatory requirements, and support product lifecycle management from initial registration through post-market activities. You'll collaborate with Quality Assurance, RD, Commercial teams, and regulatory authorities to ensure compliance while facilitating efficient product launches and maintaining existing approvals. /pPURPOSE OF THE FUNCTIONpFacilitates activities related to Compliance within TechOps team, in close collaboration with Product Quality and External Manufacturing network. /ppEnsures cross-functional alignment for critical Compliance topics and projects. /ppKeeps dashboards and compliance operations on track and resolves potential issues that may impact the timely assessment and closure of actions. /ppThe role requires strong sense of ownership, excellent communication and coordination skills in partnership with internal and external partners to ensure accuracy and timely deliverables. /pROLES AND RESPONSIBILITIESpbChange Control management: /b /pulliMaintain a CC tracker, liaise across functions to follow status, monitor coordinate implementation dates with CMOs, facilitate cross-functional meetings, makes sure change actions are completed on time (KPIs dashboard), coordinate with Supply plans for impacted post-change batches, alignment on multi-asset changes per Site in close collaboration with Quality /liliManage the Change Control Review Board. /li /ulpbDeviations management: /b /pulliEstablish and maintain Deviations tracker, liaise with CMOs to pursue critical deviations actions. /liliIn partnership with Quality, build a system allowing adequate Deviation management. /li /ulpbAnnual Reports: /b /pulliAnnually for each asset (commercial development), extract applicable list of CC implemented during the reporting period per jurisdiction, facilitate interactions alignment across functions in the context of annual report drafting and review. /li /ulpbHealth Authority Commitments: /b /pulliMaintain a Commitments tracker per Asset and map timelines /lilicoordination of actions and technical activities, make sure studies are initiated in time to generate data for submission, as needed. /liliTracking the execution of regulatory Commitments in close collaboration with Reg CMC team for each Asset. /li /ulpbCompliance of Excipients: /b /pulliCoordinate choice of material /supplier for manufacture of batches in compliance with regional country Pharmacopoeia requirements /or changes triggered by compendial updates /liliTracking execution of regulatory Commitments and preparing regular dashboards /li /ulpREQUIREMENTS:br
• Degree in biotechnology, pharmaceutical sciences or bioengineering /pp
• Relevant expertise in CMC Project Management or Quality Compliance background, or a similar role within the Biotech industry. /pp
• Additional qualifications in Quality Management or Regulatory Affairs advantageousbr
• Knowledge of medical device and IVD regulations (EU MDR/IVDR, FDA, international requirements)br
• Experience with regulatory submissions and documentation managementbr
• Strong technical writing and documentation skillsbr
• Proficiency in Microsoft Office applications (Word, Excel, PowerPoint) and preferably with document management systemsbr
• Excellent organizational abilities and attention to detailbr
• Strong analytical and problem-solving capabilitiesbr
• Effective verbal and written communication skills in Englishbr
• Ability to work both independently and collaboratively in a matrix environmentbr
• Experience with regulatory databases and submission systems preferredbr
• Knowledge of GMP, ISO 13485, and quality