Regulatory Affairs Specialist CMC

Encontrado en: beBee S ES - hace 3 semanas


SFEL RD SANT FELIU DE LLOBR, España Almirall A tiempo completo
Mission

Provide regulatory advice and prepare and maintain the chemical-pharmaceutical regulatory documentation for strategic brands for international and local products, maximising compliance with current guidelines while minimising regulatory commitments.

Tasks and Responsibilities
  • Participate in different projects (Pharma and Chemistry) developed by the company.
  • Coordinate the preparation of chemical-pharmaceutical documentation required for the presentation of Variations and Renewals of products sold by the company, as well as the modifications to be made to the active substance.
  • Define the strategy, and manage and coordinate the resolution of issues related to new variations of authorised products.
  • Contact and coordinate with the different IF Manufacturing, Quality Assurance and Quality Control departments (SAB), Reinbek and Ranke Química in order to obtain the information required for preparation of the chemical-pharmaceutical documents (CMC).
  • Evaluate and manage/respond to questions regarding chemical-pharmaceutical issues from the Industrial Area and R&D.
  • Supervise the scientific style, content and coherence of the chemical-pharmaceutical portion of the final dossier in order to minimise the commitments acquired with the authorities and, in turn, variations in the chemical-pharmaceutical portion of the dossier.
Education & specific knowledge

•    University Degree in Life Sciences (preferably Biochemistry, Biotechnological or Pharmacy...)
•    International regulatory affairs legislation in CMC topics and procedures for biologics products in both EU and non-EU Regulatory Agencies.
•    Pharmaceutical development, Analysis, Production and Quality Control of biologic products, from development to post-marketing phases.
•    High level of English.
•    Team player with ability to communicate effectively across several scientific disciplines.

Experience

2 - 3 years of experience in a similar position in a Regulatory Affairs Department.

Values

•    Care
•    Courage
•    Innovation
•    Simplicity
 


  • Regulatory Affairs Specialist CMC

    Encontrado en: beBee S ES - hace 2 semanas


    SFEL - R&D SANT FELIU DE LLOBR, España Almirall A tiempo completo

    Mission Provide regulatory advice and prepare and maintain the chemical-pharmaceutical regulatory documentation for strategic brands for international and local products, maximising compliance with current guidelines while minimising regulatory commitments. Tasks and Responsibilities Participate in different projects (Pharma and Chemistry) developed by the...

  • Regulatory Affairs Specialist CMC

    Encontrado en: beBee jobs ES - hace 4 días


    SFEL - R&D SANT FELIU DE LLOBR, España Almirall A tiempo completo

    MissionProvide regulatory advice and prepare and maintain the chemical-pharmaceutical regulatory documentation for strategic brands for international and local products, maximising compliance with current guidelines while minimising regulatory commitments.Tasks and ResponsibilitiesParticipate in different projects (Pharma and Chemistry) developed by the...

  • Biopharma Regulatory Affairs Specialist

    Encontrado en: Talent ES C2 - hace 1 semana


    Sant Cugat del Vallès, España Grifols A tiempo completo

    Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and...


  • Corbera de Llobregat, España LABIANA LIFE SCIENCES, S.A A tiempo completo

    We are looking for a _**_REGULATORY AFFAIRS _**_TRAINEE _**_to be part of the Regulatory Affairs Team of a pharmaceutical company focused in licensing and manufacturing human and veterinary medicinal products. In dependency of the Regulatory Affairs Manager, his/her main activities will be focused on _**_providing support _**_on all activities of a...

  • Pharmacokinetics and Drug Metabolism Specialist 1

    Encontrado en: beBee jobs ES - hace 6 días


    SFEL - R&D SANT FELIU DE LLOBR, España Almirall A tiempo completo

    MissionBe a member of R&D teams to provide an expert DMPK & Bioanalysis support to Large Molecule therapy projects. Implementation and validation of adequate bioanalytical strategies, with focus on PK assays, PD assays and immunogenicity assays, across the project lifecycle in a multidisciplinary environment. Coordinate sample analysis including...

  • Pharmacokinetics and Drug Metabolism Specialist 1

    Encontrado en: beBee S ES - hace 6 días


    SFEL - R&D SANT FELIU DE LLOBR, España Almirall A tiempo completo

    Mission Be a member of R&D teams to provide an expert DMPK & Bioanalysis support to Large Molecule therapy projects. Implementation and validation of adequate bioanalytical strategies, with focus on PK assays, PD assays and immunogenicity assays, across the project lifecycle in a multidisciplinary environment. Coordinate sample analysis including...

  • Corporate Head of Regulatory Affairs

    Encontrado en: beBee jobs ES - hace 2 semanas


    Distrito de Sant Martí, Barcelona, España International Staffing Consultants, Inc. A tiempo completo

    Corporate Head of Regulatory AffairsLocation: Barcelona or remote but open to commute.Job PurposeEnsure that the worldwide regulatory strategies are clearly supported and implemented in the product development, commercialization and life cycle management of the medicinal products.Major AccountabilitiesDevelopment of international regulatory strategies and...

  • Corporate Head of Regulatory Affairs

    Encontrado en: beBee S ES - hace 3 semanas


    Sant Marti, España International Staffing Consultants, Inc. A tiempo completo

    Corporate Head of Regulatory Affairs Location: Barcelona or remote but open to commute. Job Purpose Ensure that the worldwide regulatory strategies are clearly supported and implemented in the product development, commercialization and life cycle management of the medicinal products. Major Accountabilities Development of international...

  • Corporate Head of Regulatory Affairs

    Encontrado en: beBee S ES - hace 2 semanas


    Sant Marti, España International Staffing Consultants, Inc. A tiempo completo

    Corporate Head of Regulatory Affairs Location: Barcelona or remote but open to commute. Job Purpose Ensure that the worldwide regulatory strategies are clearly supported and implemented in the product development, commercialization and life cycle management of the medicinal products. Major Accountabilities Development of international...


  • Jerez de la Frontera, España Cosmewax A tiempo completo

    Descripción Buscamos un Técnico en Regulatory Affairs para nuestra sede de Jerez o Valencia. Las funciones que realizará son: - Verificar y revisar formulaciones, textos y medidas de etiquetado. - Preparar y tramitar registros de los productos finales. - Gestión de studios dermatologicos. Requisitos mínimos - Curso Experto en la Evaluación de la...

  • EMEA Regulatory Affairs Sr. Manager

    Encontrado en: beBee S ES - hace 3 semanas


    L'Hospitalet de Llobregat, España Vantage A tiempo completo

    Vantage is a leading supplier of naturally derived specialty ingredients and formulations that cater to the evolving needs of industrial and consumer markets. Through our chemistries, our customer focus and our global footprint, we are ENABLING TOMORROW’S SOLUTIONS TODAY. As a company on the move, you’ll be working as part of a collaborative team...

  • Regulatory Affairs Trainee

    Encontrado en: Talent ES C2 - hace 2 semanas


    Sant Cugat del Vallès, España Eurofragance A tiempo completo

    Why do an intership at Eurofragance?In Eurofragance you will be part of the exciting world of smells and fragrances with our Passion, Performance & Entrepreneurship values.You will grow and learn in a company in constant growth and expansion.You will have the opportunity to develop with top professionals in the sector.You will be part of a Global Company...

  • Senior Regulatory Specialist

    Encontrado en: beBee jobs ES - hace 23 horas


    Hospitalet de Llobregat, Barcelona, España Ecolab A tiempo completo

    Additional Job DescriptionAre you looking for a career in a multinational company? Ecolab is currently seeking a Senior Regulatory Specialist Biocides. This is an office-based role; the candidate may reside near one of our offices in:Vimercate (Italy)Barcelona (Spain)Northwich (UK)Monheim (Germany)Lille (France)Your ResponsibilitiesSet up the regulatory...

  • TEMP Regulatory Affairs Specialist EMEA

    Encontrado en: Talent ES C2 - hace 1 semana


    Cornellà de Llobregat, España ZimVie US Corp LLC A tiempo completo

     We are ZimVie, a publicly traded, global life sciences leader focused on restoring daily life by advancing clinical technology to improve patients’ smiles, function, and confidence. Our company is founded on a legacy of trusted brands, products, and clinical evidence made possible through an inclusive and collaborative culture that empowers our team...

  • TEMP Regulatory Affairs Specialist EMEA

    Encontrado en: Talent ES C2 - hace 4 días


    Cornellà de Llobregat, España ZimVie US Corp LLC A tiempo completo

     We are ZimVie, a publicly traded, global life sciences leader focused on restoring daily life by advancing clinical technology to improve patients’ smiles, function, and confidence. Our company is founded on a legacy of trusted brands, products, and clinical evidence made possible through an inclusive and collaborative culture that empowers our team...

  • Senior Regulatory Specialist

    Encontrado en: beBee S ES - hace 1 día


    L'Hospitalet de Llobregat, España Ecolab A tiempo completo

    Additional Job Description Are you looking for a career in a multinational company? Ecolab is currently seeking a Senior Regulatory Specialist Biocides. This is an office-based role; the candidate may reside near one of our offices in: Vimercate (Italy) Barcelona (Spain) Northwich (UK) Monheim (Germany) Lille...


  • Yunquera de Henares, Guadalajara provincia, España Grupo Crit A tiempo completo

    **Descripción**: Desde Grupo Crit nos encontramos en búsqueda de un Técnico de Asuntos Regulatorios para una gran empresa ubicada en Yunquera de Henares, Guadalajara. Formación, conocimientos y experiência necesarios: Graduado en química / Ingeniería Química / Farmacia. Máster en cosmética. Elaboración Fichas de Datos de...


  • Alcalá de Henares, España Synerlab Group A tiempo completo

    Actividades destacadas a realizar: Medical Affairs:Colaboración en todas las actividades relacionadas con las partes clínicas y preclínicas del dossier de registro de medicamentos para productos actuales y potenciales, para registro y para contestar cartas de deficiencias y variaciones regulatorias en distintos territorios. También relacionadas con food...

  • Statistician R&d

    hace 16 horas


    Sant Feliu de Llobregat, España Almirall A tiempo completo

    **Date**:14 Nov 2023 **Location**: SFEL - R&D SANT FELIU DE LLOBR, ES, ES - Spain **Company**:Almirall **Mission**: The Junior Statistician will be responsible of the design and statistics of clinical trials and clinical development projects within Almirall. The Junior Statistician will partner with senior scientists in clinical (Global Development and...

  • Clinical Operations Specialist

    Encontrado en: Talent ES C2 - hace 1 semana


    Sant Cugat del Vallès, España Grifols A tiempo completo

    Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and...