EU Regulatory Affairs Specialist

hace 16 horas


Barcelona, Barcelona, España Pmfarma A tiempo completo

**Pmfarma: A Leading International Pharmaceutical Company**

We are seeking an experienced EU Regulatory Affairs Specialist to join our team in Spain. This is a fantastic opportunity for a skilled professional to take on a pivotal role in ensuring compliance with local regulatory requirements and product registration, maintenance, and life-cycle management.

The ideal candidate will have a strong background in Regulatory Affairs within the pharmaceutical industry, with at least 2 years of experience in EU regulatory activities. They will be responsible for leading registrations, renewals, variations, and other procedures, as well as acting as the Local Qualified Person for Pharmacovigilance (LQPPV) for Spain.

Key Responsibilities:

  • Ensure all regulatory submissions align with EU/Spanish legislation, guidelines, and timelines, meeting business objectives.
  • Lead selected National Procedures (NPs), Mutual Recognition Procedures (MRPs), Decentralized Procedures (DCPs), and Repeat-Use Procedures (RUPs) on behalf of the MAH in EU, coordinating with Regulatory Authorities across EU countries, including Spain.
  • Prepare, review, publish in eCTD format, and submit dossiers for new product registrations, variations, renewals, and other regulatory filings to Spanish Health Authorities (AEMPS) and other EU Agencies.
  • Maintain accurate and up-to-date records of all regulatory activities and submissions.

What We Offer:

  • A competitive salary of €80,000 per year.
  • A comprehensive benefits package, including health insurance, pension plan, and paid time off.
  • Ongoing training and development opportunities to enhance your skills and knowledge.
  • A collaborative and dynamic work environment.

Requirements:

  • Master's degree in Pharmacy, Biotechnology, Life Sciences, or a related field.
  • Minimum 5 years of experience in Regulatory Affairs within the pharmaceutical industry, with at least 2 years focused on EU regulatory activities.
  • Excellent knowledge of Spanish and European regulations in the field of pharmaceutical law.

This is an excellent opportunity for a motivated and experienced Regulatory Affairs Specialist to take their career to the next level and contribute to the success of Pmfarma.



  • Barcelona, Barcelona, España ICON A tiempo completo

    Regulatory Affairs SpecialistICON plc is a world-leading healthcare intelligence and clinical research organization.We are currently seeking a Regulatory Affairs Specialist to join our dynamic team. As a Regulatory Affairs Specialist at ICON, you will play a crucial role in ensuring compliance with regulatory requirements for clinical trials.Main...


  • Barcelona, Barcelona, España Dsm Nutritional Products A tiempo completo

    At Dsm Nutritional Products, we are looking for a Regulatory Affairs Specialist to join our team in Barcelona. In this role, you will be responsible for providing technical support to the Perfumery and Beauty Documentation team.Key responsibilities include preparing standard documents and basic questionnaires for worldwide customers, using our internal...


  • Barcelona, Barcelona, España Dsm-Firmenich A tiempo completo

    Company Overview: DSM-Firmenich, a leading global provider of innovative products and solutions for the food and pet food industry.Job Description: As a Regulatory Affairs Specialist, you will play a crucial role in ensuring compliance with European regulations and guidelines for our product portfolio. You will work closely with cross-functional teams to...


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

    Job DescriptionWe are ZimVie, a leading global life sciences company dedicated to restoring daily life for our patients through innovative medical solutions. Our mission is built on a legacy of trusted brands and products, supported by an inclusive culture that empowers our team members to bring their best selves to work every day.About the RoleThe...


  • Barcelona, Barcelona, España Pmfarma A tiempo completo

    Company OverviewPmfarma is a leading international pharmaceutical company seeking an experienced Regulatory Affairs expert to support our EU market authorization efforts.


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

    We are ZimVie, a globally recognized leader in life sciences, dedicated to restoring daily life for patients through innovative solutions for tooth replacement and spine surgery.About the CompanyZimVie is a publicly traded corporation with a legacy of trusted brands, products, and clinical evidence, built on an inclusive and collaborative culture that...


  • Barcelona, Barcelona, España Divurgent A tiempo completo

    Join Sinclair as a Regulatory Affairs SpecialistSinclair, a global medical aesthetics organisation, is seeking an experienced Regulatory Affairs Specialist to manage the global product registration and regulatory approvals for our Energy-Based Devices (EBDs). This role will involve ensuring compliance with international regulatory authorities and supporting...


  • Barcelona, Barcelona, España Com si fos ahir A tiempo completo

    Job OverviewWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Com si fos ahir. The successful candidate will be responsible for ensuring regulatory compliance and ensuring that our medical devices meet the highest standards.About the RoleThe Regulatory Affairs Specialist will be responsible for providing expert knowledge and...


  • Barcelona, Barcelona, España Grifols A tiempo completo

    About GrifolsGrifols is a global healthcare company dedicated to improving the lives of millions of people worldwide. Since 1909, we have been working tirelessly to provide innovative medicines, solutions, and services in over 110 countries and regions.Job OverviewWe are seeking a Senior Regulatory Affairs Specialist to join our Biopharma Regulatory...


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

    We are ZimVie, a global leader in life sciences focused on restoring daily life to patients by designing innovative medical solutions. Our company is founded on a legacy of trusted brands and clinical evidence made possible through an inclusive culture that empowers our team members to bring their best selves to work every day.About the RoleAs a Senior...


  • Barcelona, Barcelona, España Sinclair EBD A tiempo completo

    Regulatory Affairs Specialist Job DescriptionSinclair EBD is seeking a skilled Regulatory Affairs Specialist to manage the global product registration and regulatory approvals for our Energy-Based Devices. As a key member of our team, you will ensure compliance with international regulatory authorities and support market entry for EBDs worldwide.About...


  • Barcelona, Barcelona, España Puig A tiempo completo

    About the OpportunityAt Puig, a leading player in the global fashion and beauty industry, we're seeking a highly skilled Regulatory Affairs Specialist to join our Research and Development team. This role is based in Barcelona, Spain.Key ResponsibilitiesEnsure regulatory compliance of finished cosmetic products throughout all stages of product...


  • Barcelona, Barcelona, España DSM A tiempo completo

    About the RoleWe are seeking an experienced Regulatory Affairs Specialist to join our team in Barcelona, Spain.This is a unique opportunity to work with a leading company in the industry, specializing in Perfumery & Beauty products.As a Regulatory Affairs Specialist, you will be responsible for ensuring compliance with regulatory requirements and providing...


  • Barcelona, Barcelona, España W. L. Gore & Associates, Inc A tiempo completo

    About the RoleWe are seeking a Chemical Regulatory Affairs Specialist to join our Fabrics team. In this role, you will focus on EMEA chemical control regulations, enabling the use, development, and movement of chemicals globally.Key ResponsibilitiesDevelop and maintain an understanding of Gore materials and relevant existing and emerging EMEA Chemical &...


  • Barcelona, Barcelona, España DSM A tiempo completo

    Barcelona, SpainHybridAt DSM, we're looking for a Regulatory Affairs Documentation Apprentice to join our team in Barcelona. If you have a passion for regulatory information and documents, this could be the perfect opportunity for you.Our Regulatory Affairs Documentation Department is responsible for collecting and maintaining all relevant regulatory...


  • Barcelona, Barcelona, España Galderma A tiempo completo

    Job DescriptionWe are seeking a highly skilled Regulatory Affairs Expert to join our team. The ideal candidate will have a strong background in CMC Regulatory Affairs and experience with topical and/or systemic drugs.Key Responsibilities:Contribute to global regulatory CMC strategies.Assess regulatory impact of proposed CMC changes and contribute to the CMC...


  • Barcelona, Barcelona, España Dsm Nutritional Products A tiempo completo

    At Dsm Nutritional Products, our team in Barcelona is looking for a skilled Documentation Specialist to join their Regulatory Affairs department. Salary: €28,000 - €35,000 per year.As a key member of the team, you will be responsible for collecting and organizing regulatory information related to our products. This involves working closely with customers...


  • Barcelona, Barcelona, España W. L. Gore & Associates, Inc A tiempo completo

    About the Role: We are seeking a Chemical Regulatory Affairs Associate to join our Fabrics team. In this role, you will focus on EMEA chemical control regulations, enabling the use, development, and movement of chemicals globally. You will work closely with government relations to understand, monitor, and shape the evolving regulatory environment. This...


  • Barcelona, Barcelona, España The Zonal Group A tiempo completo

    **Company Overview**Sinclair is a global medical aesthetics organisation founded in 1971, delivering an extensive product range worldwide. With an in-house commercial infrastructure and a network of distributors, our products are sold in 55 countries.**Job Summary**We are seeking a highly skilled Regulatory Affairs Specialist to manage global product...


  • Barcelona, Barcelona, España Dsm A tiempo completo

    Unlock your potential in a dynamic role where you will play a crucial part in ensuring compliance with regulations and delivering high-quality documentation to our customers. As a Regulatory Affairs Specialist in the Perfumery and Beauty industry, you will have the opportunity to work with a wide range of products and clients, leveraging your expertise to...