Position: Director - Regulatory Affairs
Role Summary:
Lead regulatory strategy and submissions.
Collaborate with R&D, Technical Ops, Clin Dev, etc. to advance the company’s drug portfolio in order to ensure commercial success.
Responsibilities:
- Guide development programs to meet both US and global regulatory standards.
- Provide strategic regulatory direction from product concept through market launch.
- Shape new regulatory pathways in order to benefit stakeholders.
Requirements:
- 7–12 years of regulatory experience in the pharmaceutical/biopharmaceutical industry.
- Proven track record in regulatory leadership, including 505(b)(1), 505(b)(2), 505(j), etc.
- Experience in filing and obtaining FDA and international approvals.
- Strong regulatory knowledge of drug development including CMC, preclinical, clinical, and post-marketing phases.
- Experience working with FDA and other regulatory bodies.
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