Regulatory Affairs Specialist
hace 1 mes
About Galderma
We are a leading dermatology company with a unique legacy and decades of innovation. Our focus is on delivering a science-based portfolio of premium brands and services that meet the needs of consumers and patients.
We are looking for a Regulatory Affairs Specialist to join our team. As a CMC expert, you will contribute to the development of RA-CMC strategies for geographical extension and post-approval CMC activities.
Key Responsibilities:
- Contribute to global regulatory CMC strategies
- Assess regulatory impact of proposed CMC changes and develop strategies to support change implementation
- Review data provided to support dossier preparation and identify gaps and risks
- Write and assemble CMC sections of regulatory submissions
- Develop and maintain project plans and schedules for CMC submissions
- Ensure all CMC dossiers are stored in the company database
We aim to empower each employee and promote their personal growth while ensuring business needs are met. We value diversity and respect the dignity, privacy, and personal rights of every employee.
At Galderma, we are advancing dermatology for every skin story. We look for people who focus on getting results, embrace learning, and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration.
We are establishing a new Global Capability Center in Barcelona to deploy new capabilities to support our global commercial and functional teams. Located in the upscale Eixample District, our Global Capability Center offers numerous possibilities for professional development.
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