FSP Regulatory Affairs Specialist - CMC Compliance Officer client dedicated
Thermo Fisher Scientific
Regulatory Affairs Specialist supporting CMC compliance and regulatory operations at Thermo Fisher Scientific. The role involves managing change controls, deviations, annual reports, and health authority commitments across product lifecycles in a remote position based in Belgium.
Responsibilities
- Maintain change control trackers, coordinate implementation dates with CMOs, manage review boards, and monitor KPI dashboards
- Establish and manage deviations tracking system in partnership with Quality teams and CMOs
- Prepare annual regulatory reports, extract compliance data, and facilitate cross-functional alignment per jurisdiction
- Track health authority commitments, coordinate technical activities, and ensure timely study initiation
- Coordinate excipient compliance with regional pharmacopoeia requirements and compendial updates
Requirements
- Degree in biotechnology, pharmaceutical sciences, or bioengineering
- CMC project management or quality and compliance background in biotech industry
- Knowledge of medical device and IVD regulations (EU MDR/IVDR, FDA, international)
- Experience with regulatory submissions and documentation management
- Strong technical writing and documentation skills; proficiency in Microsoft Office
- GMP, ISO 13485, and quality management systems knowledge
- Fluent English communication; ability to manage multiple projects across time zones
L'offre d'emploi a été publiée 1 Il y a un mois
Des emplois similaires qui pourraient vous intéresserBasé sur l'offre FSP Regulatory Affairs Specialist - CMC Compliance Officer client dedicated à télétravail
- ...Environmental Conditions Office Job Description As... ...our collaborative team as a Regulatory Affairs Specialist I at Thermo Fisher... ...product registrations, maintain compliance documentation, and support... ...close collaboration with Reg CMC team for each Asset. Compliance...SuggéréTravail à distanceTemps complet
- ...(Mon-Fri) Environmental Conditions Office Job Description Join Us as a Regulatory Affairs Specialist - Regulatory CMC (Operations) Coordinator - Make an Impact... ...dossier preparation activities, and ensure compliance with internal processes and regulatory...SuggéréTravail à distanceTemps complet
- ...Regulatory Affairs Specialist role supporting Chemistry, Manufacturing and Controls (CMC) documentation preparation for global regulatory submissions. The position coordinates... ...while managing regulatory records and compliance processes. Responsibilities Support...Suggéré
- ...Environmental Conditions Office Job Description Join Us as a Regulatory Affairs Associate Director - EU... ...expertise and client interface, offering strategic... ...members. • Ensures compliance with relevant organizational... ...preclinical, clinical, CMC, publishing, etc. •...SuggéréTravail à distanceEmploi contractuelStageTemps complet
- ...Thermo Fisher Scientific seeks a CMC Project Manager to lead... ...planning, stakeholder coordination, regulatory strategy support, and team... ...programs for a global client base. Responsibilities... ...strategy advice, and ensure compliance with ICH and regional requirements...Suggéré
- ...Standard (Mon-Fri) Environmental Conditions Office Job Description The Global Regulatory Lead is a key member of the global regulatory team.... ...disciplines to ensure timely filings Oversee regulatory affairs vendors involved in marketing authorization filings...Travail à distanceTemps complet
- ...Thermo Fisher Scientific seeks a Global Regulatory Lead to serve as a strategic business partner for regulatory activities across the... ...functional departments Requirements Minimum 10 years regulatory affairs experience in biopharmaceutical organizations At least 5-7...
- ...Environmental Conditions Office Job Description... ...Research Associate in our client dedicated FSP team - Belgium – Make an... ...visits to assess protocol and regulatory compliance and manage required documentation... ...as a site processes specialist, you will ensure that the...Travail à distanceTemps completTravail à domicileÉquipe de nuit
- ...Thermo Fisher Scientific seeks a Contract Specialist to draft, negotiate, and finalize... ...involves managing contract lifecycle, ensuring compliance with established parameters, and... ...within approved parameters and company/client guidelines Assess legal, financial, and...Emploi contractuel
- ...Scientific seeks a Clinical Research Associate to join a client-dedicated field service partner team in Belgium. The role... ...monitoring of clinical trial sites, ensuring protocol compliance, data integrity, and regulatory adherence across multiple sponsor environments....À distance
- ...Thermo Fisher Scientific seeks a Senior Manager of Regulatory Affairs to lead regulatory compliance and strategy across multiple product lines including medical devices, pharmaceuticals, biologics, and diagnostics. The role involves guiding global regulatory activities...
- ...please visit us at abbvie. com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube. Reporting the Head of Europe, Regulatory Policy & Intelligence. Position Overview: The Associate Director, Europe Regulatory Policy & Intelligence (RPI), will be a strong...
- ...global pharmacovigilance specialist. Our teams help clients navigate complex... ...for Pharmacovigilance and Regulatory Affairs (LCPPV/LCPRA) and serves... ...representative to ensure compliance with national pharmacovigilance... ...skills in Microsoft Office applications, including...Pour les contractantsTemps completRecrutement immédiat
- ...Wetenschappen of Communicatiewetenschappen. Je hebt minstens 5 jaar relevante werkervaring en je hebt ervaring opgebouwd in regulatory of public affairs, of je hebt ervaring in de energiesector. Je hebt een echte teamgeest, waarbij jouw collega's op jou kunnen rekenen...Travail à domicile
- ...Environmental Conditions Office Job Description Join Us as a Regulatory Affairs Associate Director-... ...expertise and client interface, offering strategic... ...team members. • Ensures compliance with relevant... ...medical affairs, commercial, CMC regulatory, Global/regional...Travail à distanceEmploi contractuelStageTemps complet
- ...Environmental Conditions Office Job Description The Clinical... ...involving both internal (client) and external partners. −... ...may also be accountable for Regulatory Authority submissions and approvals... ...of contact for regulatory/compliance audits of assigned study(s);...Travail à distanceEmploi contractuelTemps complet
- ...Environmental Conditions Office Job Description At PPD... ...actions to bring the site into compliance and decrease risks.... ...investigators in collaboration with the client company to ensure the... ...compliance with the protocol and regulatory and ICH GCP obligations, making...Travail à distanceTemps completRecrutement immédiat
- ...Platt Inc., are searching for a Sr. EHS Specialist within our EHS team to help support... ...representatives and site leadership to help improve compliance, reduce risk, support practical EHS... ...resource to site leadership teams on regulatory expectations, safety culture, employee...Pour les contractants
- ...execution of Phase I-IV clinical studies in Belgium. The role encompasses feasibility assessment, site selection, budget management, regulatory submissions, and operational oversight to deliver high-quality trial data on time and within scope. Responsibilities Lead...À distance
- ...Clinical Research Associate Level I to monitor investigator sites using risk-based approaches, ensure data accuracy, and support regulatory compliance across clinical trials. This remote role based in Belgium requires a science degree and fluency in English, French, and...À distance
- ...physiotherapist or an athletic trainer a role as a Client Success Manager at VALD could be the... ...Team Our Client Success team is dedicated to assisting clients in implementing and... ...members in over 35 countries, with 5 offices across four continents. Driven by a multidisciplinary...Travail à distanceTemps complet
- ...Thermo Fisher Scientific seeks a Regulatory Affairs Associate Director to lead global labeling strategy for pharmaceutical and biotech products. The role involves authoring regulatory documents, directing cross-functional labeling teams, and providing strategic regulatory...
- ...advancing oncology research by ensuring clinical trial quality, data integrity, patient safety, and regulatory compliance at the site level. Working within a sponsor-dedicated model, you will oversee monitoring activities across assigned investigator sites, collaborating...Travail à distanceTemps completTravail à domicile
- ...many others. The role As a Talent Acquisition Specialist, you'll join a small HR team made up of the HR Manager, an Office & HR Assistant, a Talent Acquisition... ...social events. - A great place to work: enjoy our dedicated Qover space at WeWork in central Brussels, including...Emploi contractuelTemps completÀ distance
- ...is looking for an IT Operations & Cybersecurity Specialist based in Belgium. Join a distributed technology team dedicated to delivering reliable IT operations and... ...maintain secure digital environments for multiple clients. You will work with modern cloud productivity platforms...Temps completÀ distance
- ...behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Bilingual Administrative & Client Support Assistant based in Belgium. The Bilingual Administrative & Client Support Assistant will support the daily operations of a...Temps completÀ distanceTravail à domicileTravail posté
- ...next steps. Our partner is looking for an AI Support Operations Specialist based in Belgium. Are you passionate about artificial... ...Functional Improvements: Work closely with Product, Engineering, Compliance, and internal knowledge owners to resolve issues, clarify data...Temps completÀ distance
- ...worked to support the passage of numerous bills that have benefitted close to 500 million people in developing countries. Political Affairs Internship: The role focuses on making poverty a focus of U.S., Canadian and U.K. foreign policy. This is a part-time 12-hours per...Travail à distanceTemps partielStage
- Zorg dat je als eerste jouw kandidatuur stelt voor dit mooie project! Beschikbaarheid en startdatum zijn bespreekbaar: deeltijds of voltijds startdatum kan tussen 15/08/2020 en 01/10/2020 duurtijd: 5 à 6 maanden - mogelijk verlengingTemps partielFreelance
- ...customer acquisition solutions. At CapsLock, we value people, client orientation, quality, continuous improvement, integrity, and... ...looking for a creative and result-oriented Talent Acquisition Specialist to increase our HR Team. As a Talent Acquisition Specialist...Temps completÀ distance
Voulez-vous recevoir plus d'offres d'emploi ?
S'abonner et recevoir des offres d'emploi similaires à FSP Regulatory Affairs Specialist - CMC Compliance Officer client dedicated. Soyez parmi les premiers à postuler !
