Talent.com
Qa & Regulatory Affairs Lead - Medical Devices
Qa & Regulatory Affairs Lead - Medical DevicesCencora • Madrid, Kingdom Of Spain, España
Qa & Regulatory Affairs Lead - Medical Devices

Qa & Regulatory Affairs Lead - Medical Devices

Cencora • Madrid, Kingdom Of Spain, España
Hace 2 días
Descripción del trabajo

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 everywhere. Apply today!

Job Details

Cencora Pharmalex is one of the leading service providers for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance. The success of our company resides in the expert knowledge and high motivation of our employees. Working for Pharmalex means being creative and adaptive. Our culture of continuous learning and commitment to diversity and inclusion creates an environment that allows you to build your skills and career.

Purpose

  • Lead and support CMC biologics activities for PharmaLex projects as part of a global team.
  • Provide a broad range of regulatory affairs support..
  • Proactively support clients to deliver quality reg CMC work.

Main tasks

  • Provide a wide range of flexible regulatory affairs services for different clients on a range of product types and therapeutic areas.
  • Provide leadership and knowledge-based support for biologics CMC activities (e.G. compilation and review;
  • gap analysis;
  • CMC strategies;
  • comparability exercises)

  • Provide project management for regulatory activities
  • Manage clients and other stakeholders
  • Support business development;
  • provide input into client proposals

  • Provide critical technical review of documentation based on established experience
  • Provide effective consulting support for CMC biologics
  • Experience and skills

  • Established experience in regulatory affairs activities including :
  • Module 3 IND / IMPD authoring and review
  • MAA / BLA gap analysis
  • Development of regulatory strategy
  • Scientific advice procedures
  • Submission management
  • Experience with different territories, authorization procedures and health authorities
  • Experience with development and life-cycle management products
  • Experience in biologics e.G. regulatory affairs, manufacturing, quality systems, process, analytical
  • Established experience with a wide range of biotech product types including : ATMPs, vaccines, recombinant proteins, plasma products and biosimilars.
  • Focused and able to deliver high-quality work.
  • Ability to work in a team.
  • Strong sense of responsibility.
  • Excellent written and verbal communication skills, with a particular focus on client-facing interactions.
  • Educated to at least a relevant science degree level, preferably with a higher degree in a pharmaceutical discipline.
  • At least seven years of experience in the biotech industry.
  • What Cencora offers

    Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.

    Full time

    Affiliated Companies

    Affiliated Companies : PharmaLex Spain S.L.U.

    Crear una alerta de empleo para esta búsqueda

    Qa Lead • Madrid, Kingdom Of Spain, España

    Ofertas relacionadas
    Regulatory Affairs Senior Officer CMC – Biological products Specialist

    Regulatory Affairs Senior Officer CMC – Biological products Specialist

    ASPHALION • Spain
    Asphalion is growing and we are looking for a.Regulatory Affairs Senior Officer to join our CMC unit of consultants for the pharmaceutical industry. Someone who loves to take on new challenges, to w...Mostrar más
    Última actualización: hace 5 días • Oferta promocionada
    Regulatory Affairs Associate

    Regulatory Affairs Associate

    Vetpharma • Madrid, Spain
    Veterinary medicine manufacturers.Vetpharma is the veterinary division of Chemo, part of the Insud Pharma group, providing Animal Health solutions. In Vetpharma we are a highly qualified team.We hav...Mostrar más
    Última actualización: hace más de 30 días • Oferta promocionada
    Regulatory Affairs Senior Officer Cmc - Biological Products Specialist

    Regulatory Affairs Senior Officer Cmc - Biological Products Specialist

    ASPHALION • Madrid, Kingdom Of Spain, España
    Asphalion is growing and we are looking for a.Regulatory Affairs Senior Officer to join our CMC unit of consultants for the pharmaceutical industry. Someone who loves to take on new challenges, to w...Mostrar más
    Última actualización: hace 2 días • Oferta promocionada
    Regulatory Affairs Manager

    Regulatory Affairs Manager

    Cpl Life Sciences • Madrid, Madrid, SPAIN
    Job Title : European Regulatory Affairs Manager.Location : Madrid, Spain - Hybrid.Remuneration : Competitive salary and package. Regulatory Affairs Manager opportunity working for an established pharma...Mostrar más
    Última actualización: hace más de 30 días • Oferta promocionada
    Regulatory Affairs Specialist

    Regulatory Affairs Specialist

    EPM Scientific • Community of Madrid, Spain
    We're seeking a detail-oriented and proactive.This is a fantastic opportunity for professionals with.Publish, dispatch, and archive regulatory submissions in agency-recommended formats.Ensure timel...Mostrar más
    Última actualización: hace 11 días • Oferta promocionada
    QA & Regulatory Affairs Lead - Medical Devices

    QA & Regulatory Affairs Lead - Medical Devices

    STAAR Surgical • , , Spain, España
    A leading medical device company in Spain is looking for a professional to support the implementation and maintenance of their Quality Management System (QMS). Responsibilities include assisting wit...Mostrar más
    Última actualización: hace 4 días • Oferta promocionada
    Quality And Regulatory Manager For Health Ai Products

    Quality And Regulatory Manager For Health Ai Products

    Financecolombia • Madrid, Kingdom Of Spain, España
    REGULATORY MANAGERMCR International | Executive Search.Provide regulatory advice and support to the organisation on the content of existing marketing authorisations and for products in development ...Mostrar más
    Última actualización: hace más de 30 días • Oferta promocionada
    Global Regulatory Affairs PM - Hybrid Oncology

    Global Regulatory Affairs PM - Hybrid Oncology

    BUSINESS SOLUTIONS by TakeTalent • Madrid, Comunidad de Madrid, España
    A leading biopharmaceutical company in Madrid seeks a Regulatory Affairs Project Manager to manage global regulatory projects and ensure compliance with scientific standards.The ideal candidate pos...Mostrar más
    Última actualización: hace 4 días • Oferta promocionada
    Home-based Regulatory Affairs Specialist — CTIS & CTA Lead

    Home-based Regulatory Affairs Specialist — CTIS & CTA Lead

    Indero • Madrid, Comunidad de Madrid, España
    A contract research organization is seeking a Regulatory Affairs Specialist in Madrid.The role involves preparing and submitting regulatory documentation, ensuring compliance with EU regulations, a...Mostrar más
    Última actualización: hace 18 horas • Oferta promocionada • Nueva oferta
    Regulatory Affairs Project Manager

    Regulatory Affairs Project Manager

    BUSINESS SOLUTIONS by TakeTalent • Madrid, Community of Madrid, Spain
    Regulatory Affairs Project Manager.This position has significant impact on the company and the.PharmaMar’s oncology R&D programs. MAA / NDAs, CTAs, INDs, variations, Orphan Drug Applications, Pediatri...Mostrar más
    Última actualización: hace 19 días • Oferta promocionada
    Global Regulatory Specialist, Medical Devices (Hybrid)

    Global Regulatory Specialist, Medical Devices (Hybrid)

    EPM Scientific • Madrid, Kingdom Of Spain, España
    A medical technology company in Barcelona is seeking a Regulatory Specialist with experience in medical devices.The successful candidate will develop regulatory plans, compile technical documentati...Mostrar más
    Última actualización: hace 6 horas • Oferta promocionada • Nueva oferta
    QA & Regulatory Tech - Food & Pharma

    QA & Regulatory Tech - Food & Pharma

    Nutris • Madrid, Comunidad de Madrid, España
    A leading health science company in Madrid seeks a Quality Assurance Specialist to maintain compliance and support customers in the Food Supplement Industry. Candidates should have a Bachelor's Degr...Mostrar más
    Última actualización: hace 4 días • Oferta promocionada
    Regulatory Affairs & Quality Assurence Manager

    Regulatory Affairs & Quality Assurence Manager

    Tradebe Health & Nutrition (Clinical Nutrition S.A.U) • Madrid, Spain
    Empresa especializada en elaboración de productos dietéticos y dietoterápicos, busca incorporar un Responsable de QA y Regulatory con experiencia en laboratorios de suplementación, alimentación, me...Mostrar más
    Última actualización: hace 19 días • Oferta promocionada
    Regulatory Affairs Associate - International Markets

    Regulatory Affairs Associate - International Markets

    Chemo • Azuqueca, SPAIN
    Posición : Regulatory Affairs Associate - International Markets.Localización : Azuqueca de Henares.Experiencia : al menos 4 años en funciones similares. INSUD PHARMA opera en toda la cadena de valor fa...Mostrar más
    Última actualización: hace más de 30 días • Oferta promocionada
    Hybrid CMC RA Lead — Biologics & Biosimilars

    Hybrid CMC RA Lead — Biologics & Biosimilars

    Jordan martorell s.l. • , , Spain, España
    A leading consultancy in the pharmaceutical industry is seeking a Regulatory Affairs Senior Officer to join their CMC unit. The role involves managing global CMC writing, supporting responses to reg...Mostrar más
    Última actualización: hace 18 horas • Oferta promocionada • Nueva oferta
    Regulatory Affairs Senior Officer CMC – Biological products Specialist

    Regulatory Affairs Senior Officer CMC – Biological products Specialist

    Jordan martorell s.l. • , , Spain, España
    Asphalion is growing and we are looking for a.Regulatory Affairs Senior Officer to join our CMC unit of consultants for the pharmaceutical industry. Someone who loves to take on new challenges, to w...Mostrar más
    Última actualización: hace 18 horas • Oferta promocionada • Nueva oferta
    Medical Devices Regulatory Project Manager

    Medical Devices Regulatory Project Manager

    BUSINESS SOLUTIONS by TakeTalent • madrid, España
    Taketalent is partnering with PharmaMar , a leading biopharmaceutical company dedicated to the research, development, and production of innovative oncology therapies , to find a Regulatory Af...Mostrar más
    Última actualización: hace 18 días • Oferta promocionada
    Clinical Trial Regulatory Lead

    Clinical Trial Regulatory Lead

    Meet Life Sciences • madrid, España
    About the Role We’re seeking an experienced Program Lead – Clinical Operations to provide strategic leadership and operational oversight across a portfolio of global oncology clinical programs...Mostrar más
    Última actualización: hace 14 días • Oferta promocionada