As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale.DESCRIPTION:Join 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, mainta support regulatory submissions across international markets. This position offers excellent professional development opportunities within our innovative environment focused on serving science.As 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, R&D, Commercial teams, and regulatory authorities to ensure compliance while facilitating efficient product launches and maintaining existing approvals.PURPOSE OF THE FUNCTIONFacilitates activities related to Compliance with close collaboration with Product Quality and External Manufacturing network.Ensures cross-functional alignment for critical Compliance topics and projects.Keeps dashboards and compliance operations on track and resolves potential issues that may impact the timely assessment and closure of actions.The role requires strong sense of ownership, excellent communication and coordination skills in partnership with internal and external partners to ensure accuracy and timely deliverables.ROLES AND RESPONSIBILITIESChange Control management:Maintain 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 QualityManage the Change Control Review Board.Deviations management:Establish and maintaise with CMOs to pursue critical deviations actions.ld a system allowing adequate Deviation management.Annual Reports:Annually 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.Health Authority Commitments:Maintain a Commitments tracker per Asset and map timelinescoordination of actions and technical activities, make sure studies are initiated needed.Tracking the execution of regulatory Commitments in close collaboration with Reg CMC team for each Asset.Compliance of Excipients:Coordinate choice of material /supplier for manufacture of batches in compliance with regional country Pharmacopoeia requirements /or changes triggered by compendial updatesTracking execution of regulatory Commitments and preparing regular dashboardsREQUIREMENTSDegree rmaceutical sciences or bioengineeringRelevant expertise in CMC Project Management or Quality & Compliance background, or a similar role within the Biotech industry.Additional qualifications in Quality Management or Regulatory Affairs advantageousKnowledge of medical device and IVD regulations (EU MDR/IVDR, FDA, international requirements)Experience with regulatory submissions and documentation managementStrong technical writing and documentation skillsProficiency in Microsoft Office applications (Word, Excel, PowerPoint) and preferably with document management systemsExcellent organizational abilities and attention to detailStrong analytical and problem-solving capabilitiesEffective verbal and written communication skills in EnglishAbility to work both independently and collaboratively in a matrix environmentExperience with regulatory databases and submission systems preferredKnowledge of GMP, ISO 13485, and quality management systemsAbility to manage multiple projects and meet deadlinesCustomer-focused mindset with strong interpersonal skillsDemonstrates company values of Integrity, Intensity, Innovation, and InvolvementTeam player; able to build effective relationships with internal and external stakeholders.Leadership and communication skillsExperience nning, 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.

FSP Regulatory Affairs Specialist - CMC Compliance Officer Client Dedicated

Emma

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About Thermo Fisher Scientific:

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www.thermofisher.com/

Admin access needed