Regulatory Cmc Manager

hace 2 semanas


Madrid, España Tfs Healthscience A tiempo completo

TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) partnering with biotechnology and pharmaceutical companies throughout their clinical development journey. We provide full-service capabilities, resourcing, and Functional Service Provider (FSP) solutions, helping bring life-saving treatments to patients worldwide.
Sponsor: You will be dedicated to a global pharmaceutical/biotech leader in innovative drug development, helping to bring life-changing therapies to market.
Role OverviewAs a Regulatory CMC Manager, you will play a pivotal role in overseeing and coordinating Regulatory CMC (Chemistry, Manufacturing, and Controls) activities to support tech transfer projects. You will work closely with production sites, regulatory authorities, and internal teams to ensure regulatory compliance across multiple countries and facilitate seamless project execution.
Key ResponsibilitiesDevelop and Implement Global CMC StrategiesDesign and execute comprehensive regulatory strategies to meet diverse global requirements across production sites.Manage Regulatory CMC ActivitiesOversee the preparation, submission, and management of CMC documentation for regulatory filings.Coordinate Change NotificationsManage change notifications to ensure timely and accurate regulatory updates across global markets.Stakeholder CollaborationBuild and maintain strong relationships with internal and external stakeholders, including regulatory agencies, supply chain teams, and manufacturing sites.Support Tech TransfersAlign Regulatory CMC activities with tech transfer processes, ensuring smooth transitions while maintaining compliance.QualificationsProven expertise in Regulatory CMC in a global environment, including regions such as Asia, LATAM, USA, and EU.Strong understanding of CMC regulatory requirements for pharmaceuticals, particularly solid dosage forms.Experience managing regulatory submissions and handling change control processes.Excellent communication and organizational skills to facilitate collaboration across cross-functional teams.Ability to manage complex projects and adapt plans to address unforeseen challenges.What We OfferCompetitive compensation for your expertise and contributions.Opportunity to lead high-impact global projects in a collaborative environment.Flexibility to work remotely, offering a healthy work-life balance.A chance to work with a global organization committed to innovation and patient-focused solutions.Join UsAt TFS HealthScience, we believe in creating solutions that matter, driven by shared values and a commitment to a healthier future. Join our team and be part of a company that values excellence, innovation, and collaboration, as we work together to bring new treatments to patients worldwide.

#J-18808-Ljbffr


  • Regulatory Cmc Manager

    hace 2 semanas


    Madrid, España Tfs Healthscience A tiempo completo

    TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) partnering with biotechnology and pharmaceutical companies throughout their clinical development journey. We provide full-service capabilities, resourcing, and Functional Service Provider (FSP) solutions, helping bring life-saving treatments to patients worldwide.Sponsor: You...

  • Regulatory Cmc Manager

    hace 3 semanas


    Madrid, España Tfs Healthscience A tiempo completo

    TFS Health Science is a leading global mid-size Contract Research Organization (CRO) partnering with biotechnology and pharmaceutical companies throughout their clinical development journey.We provide full-service capabilities , resourcing , and Functional Service Provider (FSP) solutions , helping bring life-saving treatments to patients worldwide.Sponsor:...

  • Regulatory Cmc Manager

    hace 2 semanas


    Madrid, España buscojobs España A tiempo completo

    TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) partnering with biotechnology and pharmaceutical companies throughout their clinical development journey. We provide full-service capabilities, resourcing, and Functional Service Provider (FSP) solutions, helping bring life-saving treatments to patients worldwide.Sponsor: You...

  • Regulatory Cmc Manager

    hace 2 semanas


    Madrid, España buscojobs España A tiempo completo

    TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) partnering with biotechnology and pharmaceutical companies throughout their clinical development journey. We provide full-service capabilities, resourcing, and Functional Service Provider (FSP) solutions, helping bring life-saving treatments to patients worldwide.Sponsor: You...

  • Regulatory CMC Manager

    hace 2 semanas


    Madrid, España TFS HealthScience A tiempo completo

    TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) partnering with biotechnology and pharmaceutical companies throughout their clinical development journey. We provide full-service capabilities, resourcing, and Functional Service Provider (FSP) solutions, helping bring life-saving treatments to patients worldwide.Sponsor: You...

  • Regulatory CMC Manager

    hace 2 semanas


    Madrid, España TFS HealthScience A tiempo completo

    TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) partnering with biotechnology and pharmaceutical companies throughout their clinical development journey. We provide full-service capabilities, resourcing, and Functional Service Provider (FSP) solutions, helping bring life-saving treatments to patients worldwide.Sponsor: You...

  • Regulatory CMC Manager

    hace 3 semanas


    Madrid, España TFS HealthScience A tiempo completo

    TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) partnering with biotechnology and pharmaceutical companies throughout their clinical development journey. We provide full-service capabilities, resourcing, and Functional Service Provider (FSP) solutions, helping bring life-saving treatments to patients worldwide.Sponsor: You...

  • Regulatory Manager

    hace 5 meses


    Madrid, España Parexel A tiempo completo

    When our values align, there's no limit to what we can achieve.Are you an experienced regulatory professional looking for a new opportunity? We are currently seeking a talented CMC Regulatory Manager (Regulatory Affairs Consultant) to join our dynamic team! This is a client dedicated project, and the role can be office or home based in various European...

  • Regulatory Manager

    hace 21 horas


    Madrid, España Parexel International A tiempo completo

    Are you an experienced regulatory professional looking for a new opportunity? We are currently seeking a talented CMC Regulatory Manager (Regulatory Affairs Consultant) to join our dynamic team! This is a client dedicated project, and the role can be office or home based in various European locations.As the CMC Regulatory Manager, you will play a vital role...

  • Regulatory Manager

    hace 21 horas


    Madrid, España Parexel International A tiempo completo

    Are you an experienced regulatory professional looking for a new opportunity? We are currently seeking a talented CMC Regulatory Manager (Regulatory Affairs Consultant) to join our dynamic team! This is a client dedicated project, and the role can be office or home based in various European locations. As the CMC Regulatory Manager, you will play a vital role...


  • Madrid, España Mabxience A tiempo completo

    Overview:The Junior Manager, Regulatory Affairs CMC is responsible to provide regulatory relevant technical assistance to development teams and ensures adequacy of CMC documentation for global regulatory submissions including specific requirements for regional registration processes.The position supports and promotes all regulatory CMC tasks throughout the...


  • Madrid, España Mabxience A tiempo completo

    Overview: The Junior Manager, Regulatory Affairs CMC is responsible to provide regulatory relevant technical assistance to development teams and ensures adequacy of CMC documentation for global regulatory submissions including specific requirements for regional registration processes. The position supports and promotes all regulatory CMC tasks throughout...

  • Regulatory Manager

    hace 8 meses


    Madrid, España Parexel A tiempo completo

    When our values align, there's no limit to what we can achieve.   Are you an experienced regulatory professional looking for a new opportunity? We are currently seeking a talented CMC Regulatory Manager (Regulatory Affairs Consultant) to join our dynamic team! This is a client dedicated project, and the role can be office or home based in various...

  • Regulatory Manager

    hace 2 días


    Madrid, España Parexel International A tiempo completo

    Are you an experienced regulatory professional looking for a new opportunity? We are currently seeking a talented CMC Regulatory Manager (Regulatory Affairs Consultant) to join our dynamic team! This is a client dedicated project, and the role can be office or home based in various European locations.As the CMC Regulatory Manager, you will play a vital role...

  • Regulatory Manager

    hace 2 días


    Madrid, España Parexel International A tiempo completo

    Are you an experienced regulatory professional looking for a new opportunity? We are currently seeking a talented CMC Regulatory Manager (Regulatory Affairs Consultant) to join our dynamic team! This is a client dedicated project, and the role can be office or home based in various European locations. As the CMC Regulatory Manager, you will play a vital...


  • Madrid, España Parexel A tiempo completo

    When our values align, there's no limit to what we can achieve.We are looking for a Senior Regulatory Affairs Manager/Consultant with 10+ years of experience in regulatory affairs, including CMC expertise.This challenging role offers the opportunity to work on diverse projects, manage client relationships, and contribute to regulatory strategies in a global...


  • Madrid, España Parexel A tiempo completo

    When our values align, there's no limit to what we can achieve.   We are looking for a Senior Regulatory Affairs Manager/Consultant with 10+ years of experience in regulatory affairs, including CMC expertise. This challenging role offers the opportunity to work on diverse projects, manage client relationships, and contribute to regulatory strategies...

  • Regulatory Manager

    hace 6 meses


    Madrid, España INSUD PHARMA, S.L.U. A tiempo completo

    Overview: **General Responsibility** The Manager, Regulatory Affairs CMC is responsible for defining and implementing global CMC strategies including regulatory relevant technical guidance to development teams and ensures adequacy of CMC documentation for global regulatory submissions. The position supports and promotes all regulatory CMC tasks throughout...


  • Madrid, Madrid, España Galderma A tiempo completo

    Galderma is a pioneering dermatology company with a rich legacy and commitment to innovation. With operations in approximately 90 countries, we deliver a diverse portfolio of premium brands and services that cater to the evolving needs of the dermatology market.We are seeking an expert Regulatory Affairs CMC Specialist to join our team in Barcelona. As a key...

  • Ra-Cmc Specialist

    hace 2 meses


    Madrid, España Galderma A tiempo completo

    With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the pure-play dermatology category leader, present in approximately 90 countries.We deliver an innovative, science-based portfolio of premium flagship brands and services that spans the full spectrum of the fast-growing dermatology market through Injectable...