Director, Regulatory Operations
1 month ago
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- Job by industries
What you will be doing
- Lead and oversee regulatory operations activities to ensure compliance with applicable regulations and guidelines.
- Develop strategies for regulatory submissions and approvals, including INDs, NDAs, BLAs, and marketing authorization applications.
- Collaborate with cross-functional teams to provide regulatory guidance and support throughout the drug development process.
- Manage regulatory submissions and timelines, ensuring accuracy and completeness of documentation.
- Stay abreast of evolving regulatory requirements and trends to inform decision-making and strategy development.
Your profile
- Bachelor's degree in a scientific or related field; advanced degree preferred.
- 8+ years of experience in regulatory affairs within the pharmaceutical or biotechnology industry.
- Strong understanding of global regulatory requirements and guidelines.
- Proven track record of successful regulatory submissions and approvals.
- Excellent communication and interpersonal skills, with the ability to collaborate effectively across teams and with regulatory agencies.
- Proven leadership experience
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