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.