Regulatory Affairs Specialist

hace 4 días

Barcelona, Barcelona, España Galderma A tiempo completo
Job Title: Regulatory Affairs Specialist

Galderma is a leading dermatology company that is committed to advancing the field of dermatology for every skin story. We are seeking a highly skilled Regulatory Affairs Specialist to join our team in Barcelona, Spain.

Job Summary

The Regulatory Affairs Specialist will be responsible for delivering innovative, breakthrough global regulatory strategies for clinical trial registration with health authorities. This role will involve creating and managing clinical trial regulatory strategy, executing clinical trial regulatory activities, and ensuring accurate and compliant dossiers.

Key Responsibilities
  • Develop and implement global regulatory strategies for clinical trials, ensuring compliance with regulatory requirements.
  • Manage clinical trial regulatory submissions, including responses to health authority queries and amendments to clinical trial dossiers.
  • Collaborate with cross-functional teams to ensure regulatory aspects are aligned with global business strategy.
  • Identify and assess risks associated with clinical regulatory submissions and recommend strategies to mitigate these risks.
  • Provide regular updates to global regulatory lead and indication regulatory leads regarding specific clinical trials.
Requirements
  • Knowledge and understanding of regulatory requirements for pharmaceutical/biological product development.
  • Experience with performing regulatory submissions in at least one key regulatory region.
  • Excellent communication and teamwork skills, with the ability to work in a fast-paced environment.
  • Ability to identify opportunities/major issues and to communicate impact.
  • Demonstrated ability to deal with rapid change.
What We Offer
  • A competitive compensation package with bonus structure and extended benefit package.
  • A hybrid work culture that allows for flexibility and work-life balance.
  • The opportunity to work with a diverse and inclusive team that values professionalism, collaboration, and a friendly, supportive ethos.
  • A growing company that believes in ownership from day one, where everyone is empowered to grow and take on accountability.
Next Steps
  • If your profile is a match, we will invite you for a first virtual conversation with the recruiter.
  • The next step is a virtual conversation with the hiring manager.
  • The final step is a panel conversation with the extended team.

  • Regulatory Affairs Specialist

    hace 4 semanas

    Barcelona, Barcelona, España Galderma A tiempo completo

    Regulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Galderma. As a key member of our Regulatory Affairs department, you will be responsible for preparing and updating CMC dossier sections for assigned products.Key Responsibilities:Contribute to global regulatory CMC strategiesAssess regulatory impact...

  • Regulatory Affairs Specialist

    hace 4 semanas

    Barcelona, Barcelona, España Galderma A tiempo completo

    Regulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Galderma. As a key member of our Regulatory Affairs department, you will be responsible for preparing and updating CMC dossier sections for assigned products.Key Responsibilities:Contribute to global regulatory CMC strategiesAssess regulatory impact...

  • Regulatory Affairs Specialist

    hace 2 días

    Barcelona, Barcelona, España Algaktiv A tiempo completo

    Regulatory Affairs SpecialistAlgaktiv is a biotechnology and microalgae specialist company headquartered in Barcelona, Spain, working with skincare brands to create unique formulations using high-performance active ingredients. We are seeking a highly skilled and motivated Regulatory Affairs Specialist to join our team.Key ResponsibilitiesEnsure compliance...

  • Regulatory Affairs Specialist

    hace 2 días

    Barcelona, Barcelona, España Algaktiv A tiempo completo

    Regulatory Affairs SpecialistAlgaktiv is a biotechnology and microalgae specialist company headquartered in Barcelona, Spain, working with skincare brands to create unique formulations using high-performance active ingredients. We are seeking a highly skilled and motivated Regulatory Affairs Specialist to join our team.Key ResponsibilitiesEnsure compliance...

  • Regulatory Affairs Specialist

    hace 2 días

    Barcelona, Barcelona, España Grifols A tiempo completo

    Join Our Team as a Regulatory Affairs SpecialistWe are committed to fostering an inclusive environment and promoting diversity within our organization. As a Regulatory Affairs Specialist, you will play a crucial role in ensuring compliance with regulatory requirements and facilitating the registration and renewal of our products.Key Responsibilities:Prepare...

  • Regulatory Affairs Specialist

    hace 2 días

    Barcelona, Barcelona, España Grifols A tiempo completo

    Join Our Team as a Regulatory Affairs SpecialistWe are committed to fostering an inclusive environment and promoting diversity within our organization. As a Regulatory Affairs Specialist, you will play a crucial role in ensuring compliance with regulatory requirements and facilitating the registration and renewal of our products.Key Responsibilities:Prepare...

  • Packaging Regulatory Affairs Specialist

    hace 2 días

    Barcelona, Barcelona, España Grifols A tiempo completo

    Job Title: Packaging Regulatory Affairs SpecialistWe are seeking a highly skilled Packaging Regulatory Affairs Specialist to join our Biopharma Regulatory department at Grifols.Key Responsibilities:Prepare, review, and follow up on documentation generated at the Regulatory Affairs department or needed for a regulatory submission, ensuring timeliness,...

  • Packaging Regulatory Affairs Specialist

    hace 2 días

    Barcelona, Barcelona, España Grifols A tiempo completo

    Job Title: Packaging Regulatory Affairs SpecialistWe are seeking a highly skilled Packaging Regulatory Affairs Specialist to join our Biopharma Regulatory department at Grifols.Key Responsibilities:Prepare, review, and follow up on documentation generated at the Regulatory Affairs department or needed for a regulatory submission, ensuring timeliness,...

  • Regulatory Affairs Specialist

    hace 4 semanas

    Barcelona, Barcelona, España Empresa Reconocida A tiempo completo

    **Job Summary**Empresa Reconocida is seeking a highly skilled Regulatory Affairs Specialist to join their team in Barcelona. As a key member of the Regulatory Affairs Team, you will be responsible for ensuring regulatory requirements are met for new product development and design changes to established legacy devices.**Key Responsibilities:**Prepare...

  • Regulatory Affairs Specialist

    hace 4 semanas

    Barcelona, Barcelona, España Empresa Reconocida A tiempo completo

    **Job Summary**Empresa Reconocida is seeking a highly skilled Regulatory Affairs Specialist to join their team in Barcelona. As a key member of the Regulatory Affairs Team, you will be responsible for ensuring regulatory requirements are met for new product development and design changes to established legacy devices.**Key Responsibilities:**Prepare...

  • Regulatory Affairs Specialist

    hace 4 semanas

    Barcelona, Barcelona, España Galderma A tiempo completo

    Job Title: Regulatory Affairs CMC SpecialistGalderma is seeking a highly skilled Regulatory Affairs CMC Specialist to join our team. As a key member of our Regulatory Affairs department, you will be responsible for preparing and updating CMC dossier sections for assigned products.Key Responsibilities:Contribute to global regulatory CMC strategies and assess...

  • Regulatory Affairs Specialist

    hace 4 semanas

    Barcelona, Barcelona, España Galderma A tiempo completo

    Job Title: Regulatory Affairs CMC SpecialistGalderma is seeking a highly skilled Regulatory Affairs CMC Specialist to join our team. As a key member of our Regulatory Affairs department, you will be responsible for preparing and updating CMC dossier sections for assigned products.Key Responsibilities:Contribute to global regulatory CMC strategies and assess...

  • Regulatory Affairs Specialist

    hace 4 semanas

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

    {"title": "Regulatory Affairs Specialist", "description": "Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Galderma Pharma S.A. in Barcelona. As a key member of our Regulatory Affairs department, you will be responsible for preparing and updating CMC dossier sections for assigned products, contributing to global...

  • Regulatory Affairs Specialist

    hace 4 semanas

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

    {"title": "Regulatory Affairs Specialist", "description": "Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Galderma Pharma S.A. in Barcelona. As a key member of our Regulatory Affairs department, you will be responsible for preparing and updating CMC dossier sections for assigned products, contributing to global...

  • Regulatory Affairs Specialist

    hace 2 días

    Barcelona, Barcelona, España Galderma A tiempo completo

    Job Title: Regulatory Affairs CMC SpecialistWe are seeking a highly skilled Regulatory Affairs CMC Specialist to join our team at Galderma. As a key member of our Regulatory Affairs department, you will be responsible for preparing and updating the CMC (Chemistry, Manufacturing and Control) dossier sections of assigned products.Key...

  • Regulatory Affairs Specialist

    hace 3 días

    Barcelona, Barcelona, España Galderma A tiempo completo

    Job Title: Regulatory Affairs CMC SpecialistWe are seeking a highly skilled Regulatory Affairs CMC Specialist to join our team at Galderma. As a key member of our Regulatory Affairs department, you will be responsible for preparing and updating the CMC (Chemistry, Manufacturing and Control) dossier sections of assigned products.Key...

  • Regulatory Affairs Specialist

    hace 1 día

    Barcelona, Barcelona, España Galderma A tiempo completo

    Job Title: Regulatory Affairs CMC SpecialistGalderma is seeking a highly skilled Regulatory Affairs CMC Specialist to join our team. As a key member of our Regulatory Affairs department, you will be responsible for preparing and updating the CMC dossier sections of assigned products.Key Responsibilities:Contribute to global regulatory CMC strategies and...

  • Regulatory Affairs Specialist

    hace 23 horas

    Barcelona, Barcelona, España Galderma A tiempo completo

    Job Title: Regulatory Affairs CMC SpecialistGalderma is seeking a highly skilled Regulatory Affairs CMC Specialist to join our team. As a key member of our Regulatory Affairs department, you will be responsible for preparing and updating the CMC dossier sections of assigned products.Key Responsibilities:Contribute to global regulatory CMC strategies and...

  • Regulatory Affairs Specialist

    hace 1 mes

    Barcelona, Barcelona, España Galderma A tiempo completo

    Job Title: Regulatory Affairs SpecialistLocation: Remote (hybrid)Job Description:The Regulatory Affairs Specialist delivers innovative, breakthrough global regulatory strategies for clinical trial registration with health authorities. The RA Specialist is responsible for regulatory aspects related to clinical trial regulatory submissions in alignment with...

  • Regulatory Affairs Specialist

    hace 4 semanas

    Barcelona, Barcelona, España Galderma A tiempo completo

    Job Title: Regulatory Affairs SpecialistLocation: Remote (hybrid)Job Description:The Regulatory Affairs Specialist delivers innovative, breakthrough global regulatory strategies for clinical trial registration with health authorities. The RA Specialist is responsible for regulatory aspects related to clinical trial regulatory submissions in alignment with...