Director, Regulatory Affairs
Director, Regulatory Affairs 1363917
Location: Boston, MA (Hybrid)
Science/ Focus: CRISPR Technology
Therapeutic Areas: Oncology
Job Overview: Reporting into the SVP, Clinical Development, this position will provide strategic guidance and advice to ensure efficient and compliant product development. In addition you will lead US submission work and collaborate with CRO to support global regulatory filings.
- Provide regulatory expertise and advice for product development, including clinical research, regulatory compliance, and nonclinical study requirements.
- Collaborate with CRO and niche providers to support global regulatory filings.
- Monitor the regulatory environment and assess the impact of new and changing regulations on research and development programs.
- Bachelors degree in a scientific discipline is required, advanced degree is preferred
- 8+ years of direct regulatory experience in pharmaceutical or biotechnology industry.
- Solid knowledge of drug development process and regulatory requirements
- Oncology experience preferred.
Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
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