Senior Regulatory Strategist

hace 3 días

Barcelona, Barcelona, España G&L Scientific A tiempo completo

This role can be based in either our
Barcelona
,
Belfast
or
London
Office. We work on a hybrid basis.

Ready to dive into some seriously meaningful science? We're looking for a seasoned
CMC Regulatory Affairs pro
who loves complex challenges, global coordination, and shaping regulatory strategy for a high-impact vaccine portfolio. You'll step in as our
Senior Regulatory Strategist
, owning several major upcoming submissions—including:

  • Swapping out an
    in vivo potency assay
    for a shiny new
    in vitro method
  • Implementing new
    potency reference vaccine
    replacements

If leading cross-functional teams, navigating global health authorities, and crafting impeccable regulatory dossiers sounds like your kind of adventure, read on.


Education

  • Master's degree or higher in chemistry, pharmacy, biology, or similar (we'll be extra impressed if you have a
    PhD
    ).


What You Bring

  • 8+ years
    in CMC Regulatory Affairs—bonus points if you've wrangled global lifecycle submissions for vaccines.
  • Hands-on experience with:
  • Registering
    new analytical methods
  • Potency assay
    development and validation
  • Reference standard
    strategy and maintenance
  • A proven track record of
    leading multiple projects
    , shaping CMC regulatory strategy, and authoring major submissions (BLAs, MAAs, variations—your bread and butter).
  • Deep understanding of how vaccines are developed, manufactured, tested, and shipped.
  • Fluency in global CMC frameworks: EMA, FDA, WHO, and friends.
  • Confidence and skill in influencing, negotiating, and keeping everyone—from internal teams to regulators—aligned and energized.


Who You Are

  • Someone who can jump into a new environment and take the wheel
    fast
    .
  • A natural organizer with top-tier project management and multitasking superpowers.
  • An excellent communicator who can bring clarity to complex topics.
  • Empathetic, collaborative, and adept at navigating a multi-cultural, multi-disciplinary matrix (no small feat).
  • A relationship-builder who can negotiate without friction and keep the goodwill flowing.

  • Brand Strategist Senior

    hace 5 días

    Barcelona, Barcelona, España eMascaro A tiempo completo

    SOBRE LA EMPRESAEn eMascaró diseñamos el futuro digital del lujo, la hotelería, la cultura y los destinos icónicos. Somos un hub estratégico donde las marcas evolucionan, se diferencian y amplifican su valor a través de experiencias digitales memorables.Desde Barcelona, impulsamos proyectos WOW para marcas que lideran su industria: hoteles 5 estrellas,...

  • Senior Regulatory Reporting Associate

    hace 2 semanas

    Barcelona, Barcelona, España N26 A tiempo completo

    Please Note : This role can be performed remotely. However, any employee based in our Berlin or Barcelona locations is required to work on a hybrid scheduleAbout The OpportunityWe are looking for a Senior Regulatory Reporting Associate to join our growing team. If you are passionate about financial and regulatory reporting and want to make a real impact,...

  • Senior Regulatory Affairs

    hace 1 semana

    Barcelona, Barcelona, España PharmaLex A tiempo completo

    Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals...

  • Experienced iGaming Professionals French/Italian/Spanish

    hace 7 días

    Barcelona, Barcelona, España jobsonboard A tiempo completo

    Location: [Remote / Hybrid /on-site] Department: Multidisciplinary Job Type: Full-Time About the Opportunity We are looking for seasoned industry experts to join our talent pipeline. As we continue to scale our operations across multiple regulated jurisdictions, we are seeking individuals who have a proven track record of driving GGR (Gross Gaming Revenue),...

  • Regulatory Affairs Specialist

    hace 2 semanas

    Barcelona, Barcelona, España Prinova Europe A tiempo completo

    Regulatory Affairs Specialist (Full-time, Permanent)Unlock your potential with PrinovaWe are Prinova, a leading global supplier of ingredients and premix manufacturing solutions and trusted by the world's best-known food, beverage, and nutrition brands.Part of the NAGASE Group, our expertise lies in Ingredient Distribution, Manufacturing Solutions, and...

  • Regulatory Affairs Expert

    hace 2 semanas

    Barcelona, Barcelona, España Project Delivery Partners A tiempo completo

    Regulatory Affairs ExpertJob Description:Position Title: CMC RA ExpertLocation: BarcelonaType of Contract: Full-Time / On sitePharmEng Technology, an Efor Group of Companies, is a leading pharmaceutical and biopharmaceutical consulting company committed to providing innovative solutions to the challenges facing our industries. We pride ourselves on our...

  • Quality and Regulatory Director

    hace 2 semanas

    Barcelona, Barcelona, España ARTO A tiempo completo

    Position OverviewThe Director of Quality and Regulatory Affairs will play a central role in defining and executing the organization's overall quality and regulatory roadmap. This position oversees the Quality Control, Quality Assurance, and Regulatory Affairs functions, ensuring that operations, systems, and products consistently meet applicable GxP and...

  • Regulatory Affairs Expert

    hace 1 semana

    Barcelona, Barcelona, España Project Delivery Partners A tiempo completo

    Position Title: CMC RA Expert Location: Barcelona Type of Contract: Full-Time / On site PharmEng Technology, an Efor Group of Companies, is a leading pharmaceutical and biopharmaceutical consulting company committed to providing innovative solutions to the challenges facing our industries. We pride ourselves on our dedication to quality, safety, and...

  • Regulatory Affairs Expert

    hace 2 semanas

    Barcelona, Barcelona, España Project Delivery Partners A tiempo completo

    Job Description: Position Title: CMC RA ExpertLocation: BarcelonaType of Contract: Full-Time / On sitePharmEng Technology, an Efor Group of Companies, is a leading pharmaceutical and biopharmaceutical consulting company committed to providing innovative solutions to the challenges facing our industries. We pride ourselves on our dedication to quality,...

  • Regulatory Consultant

    hace 2 semanas

    Barcelona, Barcelona, España ERM A tiempo completo

    Regulatory Consultant – Toxicology (REACH)ERM is the world's largest pure-play sustainability consultancy and we have been named as a leader in the ESG & Sustainability Consultancy industry, according to new independent research. We have an impressive client base including over 50% of global Fortune 500 companies. Our diverse team of world-class experts...