Regulatory Affairs Specialist
2 semanas atrás
Gilead Sciences, Inc. is seeking a highly skilled Regulatory Affairs Manager to join our team. As a key member of our regulatory affairs group, you will be responsible for ensuring compliance with regulatory requirements and guidelines for our cell therapy products.
Key Responsibilities:
- Develop and implement regulatory strategies to support the development and commercialization of cell therapy products
- Collaborate with cross-functional teams to ensure regulatory compliance and quality
- Prepare and submit regulatory documents, including INDs, NDAs, and MAAs
- Provide regulatory guidance and support to internal stakeholders
Requirements:
- Advanced degree in a life science or related field
- Minimum 5 years of experience in regulatory affairs, preferably in the biotechnology or pharmaceutical industry
- Strong knowledge of regulatory requirements and guidelines for cell therapy products
- Excellent communication and project management skills
What We Offer:
- Opportunity to work on cutting-edge cell therapy products
- Collaborative and dynamic work environment
- Competitive salary and benefits package
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