Regulatory Affairs Strategy Specialist

hace 3 semanas


Barcelona, Barcelona, España Galderma A tiempo completo

Galderma: A Dermatology Category Leader

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We are Galderma, a pure-play dermatology category leader with a unique legacy in dermatology and decades of cutting-edge innovation. Our company is present in approximately 90 countries, delivering an innovative, science-based portfolio of premium flagship brands and services that spans the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermo-cosmetics, and Therapeutic Dermatology.

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About the Role

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We are seeking a skilled Regulatory Affairs Strategist to join our team in Barcelona, Spain (hybrid). As a key member of our Global R&D team, you will be responsible for delivering innovative, breakthrough global regulatory strategies for clinical trial registration with health authorities.

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Key Responsibilities:

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  • Create and manage clinical trial regulatory strategy for biologics, executing clinical trial regulatory activities in alignment with agreed clinical timelines.">
  • Ensure accurate and compliant dossiers for clinical trial regulatory submissions.">
  • Archiving clinical trial documentation.">
  • Manage health authority interaction for assigned regions in alignment with agreed regulatory strategy.">
  • Identify and assess risks associated with the clinical regulatory submissions and recommend strategies to mitigate these risks.">
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Requirements:

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To succeed in this role, you will need:

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  • Knowledge and understanding of regulatory requirements for pharmaceutical/biological product development.">
  • Experience with performing regulatory submissions in at least one key regulatory region.">
  • Excellent team interaction skills along with demonstrated ability to work on a cross-functional team.">
  • Ability to identify opportunities/major issues and to communicate impact.">
  • Demonstrated ability to deal with rapid change.">
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What We Offer

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We offer a competitive compensation package with a salary range of €55,000 - €75,000 per annum, depending on experience, plus bonus structure and extended benefit package. You will also have the opportunity to work in a hybrid work culture and participate in feedback loops, during which a personalized career path will be established.

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Award-Winning Company Culture

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We value diversity and inclusion, embracing what every member of our team brings. Our company culture is built on professionalism, collaboration, and a friendly, supportive ethos, making it the perfect environment for people to thrive and excel in what they do.

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Join Our Team

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At Galderma, we empower each employee and promote their personal growth while ensuring business needs are met now and into the future. If your profile is a match, we will invite you for a first virtual conversation with the recruiter, followed by a virtual conversation with the hiring manager, and finally, a panel conversation with the extended team.



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