Regulatory Affairs Associate

hace 3 semanas

Barcelona, España AstraZeneca A tiempo completo

**Location: Barcelona (On-site)**

Are you passionate about **science**, **drug development**, **project management **and **regulatory affairs**?

At AstraZeneca, we are driven by innovation and our dedication to make a real-life difference in patients’ lives. That difference starts with you. We need people who share our passion for science and determination to meet patients’ needs around the world. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. Does this match your skills and ambitions for the future? Then join us to be part of the development of innovative treatments for **Respiratory and Immunology (R&I) diseases.**

We are now looking for passionate colleagues to join our Regulatory Affairs Management team as **Regulatory Affairs Associates (RAA). **With us, you will specialise in providing regulatory administrative support to the Global Regulatory project teams, to ensure the delivery of business objectives.

The role is based at AstraZeneca’s new R&D site in **Barcelona, Spain**. We’re proud to be opening a hub in Barcelona, where our dynamic and collaborative team will make greater strides in bringing life-changing medicines to patients worldwide. This new hub offers exciting opportunities at the forefront of science, and the chance to be part of a team that learns and grows together. We need self-starters with the skills, determination, and passion necessary to change lives.

Our Barcelona hub has been created to achieve the next wave of breakthroughs that help us do what’s never been done before, as we expand our global footprint. Harnessing data and using the best technology solutions available allow us to positively impact science. Up to 500 R&D specialists will be hired to work at our hub in the coming two years. We want you to join us in transforming medicine and developing new treatment options that will change the lives of patients globally.

**What you’ll do**

**Your main accountabilities/responsibilities**:

- Document management including uploading and tracking regulatory files and systems according to established AstraZeneca procedures and regulatory requirements.
- Planning, preparing and executing simple submissions, and assisting with the preparation and planning of regulatory dispatches.
- Be the interface with Health Authorities and its systems for designated regulatory tasks e.g. management of user fees, receipt of incoming FDA correspondence, ordering EudraCT number, EudraLink support, use of HA Portals.
- Responsible for the ordering and tracking of specific regulatory requirements such as Registration samples, Certificates of Pharmaceutical Product, Legal documentation e.g. Letters of Authorisation, Powers of Attorney, Translations of regulatory documentation.
- Provide support across the group for assigned non-drug project roles & responsibilities e.g. act as a designated point of contact or superuser.
- Provide coaching, mentoring and knowledge sharing within the RAM skill group.
- Contribute to process improvement.

**Essential for the role**
- Relevant qualification and/or experience in science, administration, or IT.
- Relevant experience within the biopharmaceutical industry, or other relevant experience.
- Project Management skills.
- Experience in document management and tracking databases.

**Desirable for the role**
- Some regulatory/medical/technical experience.
- Some knowledge of regulatory submission, compilation, publishing and approval processes, standards, systems and tools.
- Veeva Vault experience

**So, what’s next?

  • Cmc Regulatory Affairs Associate Director

    hace 2 semanas

    Barcelona, España AstraZeneca A tiempo completo

    **Location: Barcelona, Spain (we requiere 3 days working from the office and 2 days working from home** Our **Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs** function delivers expert CMC regulatory input for projects spanning across the product lifecycle and leads the regulatory strategy for the development, manufacturing and testing of...

  • Regulatory Affairs Associate

    hace 3 semanas

    Barcelona, España Argenta A tiempo completo

    **Who are we?** **The Opportunity** Due to continued growth we are looking to recruit a Regulatory Affairs Associate (specifically for feed) to join our consultancy. You will get the opportunity to work alongside our experienced team on a variety of challenging and innovative projects within the animal nutrition sector. Day to day you will manage our...

  • Regulatory Affairs Associate

    hace 7 días

    Barcelona, España Talent A tiempo completo

    Regulatory Affairs AssociateWith 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...

  • Regulatory Affairs Associate

    hace 1 semana

    Barcelona, España Galderma Pharma S.A A tiempo completo

    Regulatory Affairs AssociateWith 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...

  • Regulatory Affairs Associate

    hace 1 semana

    Barcelona, España Galderma Pharma S.A A tiempo completo

    Regulatory Affairs AssociateWith 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...

  • Regulatory Affairs Associate

    hace 1 día

    Barcelona, Barcelona, España Galderma Pharma S.A A tiempo completo

    Regulatory Affairs AssociateWith 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...

  • Regulatory Affairs Specialist

    hace 1 semana

    Barcelona, Barcelona, España BELAB SERVICES - regulatory international experts A tiempo completo

    BELAB SERVICES - Regulatory International ExpertsJob Description:We are seeking a highly skilled Regulatory Affairs Specialist with experience in regulatory compliance for cosmetic products, OTC, and dietary supplements in the U.S. and Canadian markets. The ideal candidate will have a strong educational background in Chemistry, Pharmacy, or a related field,...

  • Associate Director, Global Regulatory Affairs

    hace 3 semanas

    Barcelona, España Alexion Pharmaceuticals,Inc. A tiempo completo

    Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and...

  • Regulatory Affairs Associate

    hace 7 días

    Barcelona, España Talent A tiempo completo

    Global Life Science Hub has partnered with a one-of-a-kind, global CDMO that specializes in providing comprehensive development and manufacturing services. With an additional 50% growth expected in Europe site, we’re searching for a Regulatory Affairs Associate who will manage the relationships with key suppliers and build your own technical specialization...

  • International Regulatory Affairs Manager

    hace 2 días

    Barcelona, Barcelona, España Belab Services - Regulatory International Experts A tiempo completo

    About the RoleWe are looking for a talented Regulatory Affairs Specialist to join our dynamic team at Belab Services - Regulatory International Experts.Job Summary:This role involves providing regulatory expertise and guidance to ensure compliance with regulatory requirements for cosmetic products, OTC, and dietary supplements in the U.S. and Canadian...

  • Regulatory Affairs Specialist

    hace 23 horas

    Barcelona, Barcelona, España Zimvie Us Corp Llc A tiempo completo

    We are ZimVie, a global life sciences leader in innovative tooth replacement and spine surgery solutions. Our mission is to restore daily life to our patients through trusted brands, products, and clinical evidence.About the Role: As a Regulatory Affairs Senior Specialist, you will lead technical documentation preparation, including biocompatibility,...

  • Regulatory Affairs Specialist

    hace 3 días

    Barcelona, Barcelona, España ZimVie US Corp LLC A tiempo completo

    Job OverviewWe are seeking a highly skilled Regulatory Affairs Senior Specialist EMEA M/F to join our team at ZimVie, a global life sciences leader. This is an exciting opportunity to contribute to the development of innovative medical device solutions and work in a collaborative environment that values diversity and inclusion.The successful candidate will...

  • Regulatory Affairs Specialist

    hace 3 días

    Barcelona, Barcelona, España Chemo A tiempo completo

    Job DescriptionAbout Us: Chemo is a leading pharmaceutical company with over 40 years of history and a global presence in 50 countries. We specialize in research, development, manufacturing, and marketing of active pharmaceutical ingredients and medicines for human and veterinary use.We are seeking a highly motivated Regulatory Affairs Associate to join our...

  • Regulatory Affairs Associate

    hace 7 días

    Barcelona, España Talent 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...

  • Regulatory Affairs Professional

    hace 3 días

    Barcelona, Barcelona, España Aldwych Consulting A tiempo completo

    Aldwych Consulting is a renowned pharmaceutical company with over 40 years of experience in research, development, and manufacturing of active pharmaceutical ingredients and medicines for human and veterinary use. Our company, Chemo, is a world leader in R&D and manufacturing of value-added active pharmaceutical ingredients and medicines with diverse product...

  • Regulatory Affairs Manager

    hace 7 días

    Barcelona, Barcelona, España Talent A tiempo completo

    Job Title: Sr. Regulatory LeadWe are seeking a highly experienced regulatory professional to join our team on a dedicated opportunity with 8 years of experience in Regulatory Affairs.Key Responsibilities:Develop global regulatory strategies for projects/products within assigned portfolios, working closely with Regional Scientific Affairs teams.Collaborate...

  • Regulatory Affairs Director

    hace 7 días

    Barcelona, Barcelona, España Talent A tiempo completo

    Job OverviewThe Talent is seeking a highly skilled Regulatory Affairs Director to lead our regulatory strategy and manage compliance in EMEA. This role will report directly to the Director of Global Regulatory Affairs.

  • Regulatory Affairs

    hace 1 semana

    Barcelona, España JR Spain A tiempo completo

    Buscamos un Regulatory Affairs Specialist cuya misión será el aseguramiento del cumplimiento regulatorio de las fragancias para su aplicación, dando soporte regulatorio tanto a nivel interno a los departamentos que lo necesiten y externo a Clientes.Entre sus principales funciones se encuentra el análisis y actualización de datos regulatorios en...

  • Regulatory Affairs Trainee

    hace 4 semanas

    Barcelona, España HARTMANN A tiempo completo

    Únete a nuestro equipo como **Regulatory Affairs Trainee** ESP-Mataró (Barcelona) Aprovecha la nueva oportunidad que te ofrece HARTMANN en el **Área de Regulatory Affairs**. **Responsabilidades** - En relación con las comunicaciones de puesta en el mercado a la AEMPS por cada producto sanitario que ponemos en el mercado: - Reunir la documentación...

  • Regulatory Affairs Specialist

    hace 3 días

    Barcelona, Barcelona, España BELAB SERVICES - regulatory international experts A tiempo completo

    BELAB SERVICES is a leading international regulatory firm.We are seeking an experienced Regulatory Affairs Specialist with expertise in cosmetic products, OTC, and dietary supplements in the U.S. and Canadian markets.Key Responsibilities:Ensure regulatory compliance for cosmetic, OTC, and dietary supplement products in the U.S. and Canadian markets.Prepare,...