Regulatory Affairs Specialist
hace 2 semanas
About Galderma
Galderma is a leading dermatology company with a unique legacy in the field. With a presence in approximately 90 countries, we deliver innovative, science-based solutions that meet the needs of consumers and patients. Our focus is on advancing dermatology for every skin story, and we're committed to empowering our employees to grow and succeed.
Job Summary
We're seeking a highly skilled Regulatory Affairs Strategist to join our team in Barcelona, Spain. As a key member of our Global Regulatory Affairs team, you'll be responsible for delivering innovative, breakthrough global regulatory strategies for clinical trial registration with health authorities.
Key Responsibilities
- Creating and managing clinical trial regulatory strategy for biologics
- Executing clinical trial regulatory activities in alignment with agreed clinical timelines, including responses to health authority queries, amendments to clinical trial dossiers, regulatory SUSAR reporting, or any other regulatory activities as needed
- Oversight of clinical trial regulatory submissions, ensuring accurate and compliant dossiers
Requirements
- Proven experience in regulatory affairs, with a focus on clinical trial registration and regulatory submissions
- Strong knowledge of global regulatory requirements and guidelines
- Excellent communication and project management skills
What We Offer
- A dynamic and supportive work environment
- Opportunities for professional growth and development
- A competitive salary and benefits package
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