Regulatory Affairs Strategy Specialist
hace 3 semanas
Galderma: A Dermatology Category Leader
">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.
">About the Role
">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.
">Key Responsibilities:
">- ">
- 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.">
Requirements:
">To succeed in this role, you will need:
">- ">
- 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.">
What We Offer
">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.
">Award-Winning Company Culture
">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.
">Join Our Team
">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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