Regulatory Affairs Specialist
hace 2 semanas
Job Title: Regulatory Affairs Strategist
Location: Barcelona, Spain (hybrid)
Job Description:
The Regulatory Affairs Strategist plays a critical role in delivering innovative, breakthrough global regulatory strategies for clinical trial registration with health authorities. This position is responsible for regulatory aspects related to clinical trial regulatory submissions in alignment with the global business strategy and in partnership with the functional subject matter experts within the Global R&D.
Key Responsibilities:
- Developing and managing clinical trial regulatory strategy for biologics, ensuring alignment with global business objectives.
- Executing clinical trial regulatory activities in accordance with agreed clinical timelines, including responses to health authority queries, amendments to clinical trial dossiers, regulatory SUSAR reporting, and other regulatory activities as needed.
- Oversight of clinical trial regulatory submissions, ensuring accurate and compliant dossiers.
About Galderma:
Galderma is a leading dermatology company with a unique legacy and decades of innovation. We deliver a science-based portfolio of premium flagship brands and services that spans the full spectrum of the dermatology market. Our focus is on advancing dermatology for every skin story, and we aim to empower each employee and promote their personal growth while ensuring business needs are met.
What We Offer:
- A dynamic and collaborative work environment.
- Opportunities for professional development and growth.
- Access to global career opportunities.
Requirements:
- Strong understanding of regulatory affairs and clinical trial management.
- Excellent communication and project management skills.
- Ability to work in a fast-paced environment and prioritize multiple tasks.
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