Director of Regulatory Affairs

We are searching for a Sr/Director of Regulatory Affairs for a small clinical-stage startup focused on developing immunotherapies for cancer. Their pipeline includes targeting various pediatric and adult blood and solid organ malignancies.

We are seeking an experienced Sr/Director of Regulatory Affairs. The Sr/Director of Regulatory Affairs will lead regulatory strategy and drive the successful development of therapeutic candidates through preclinical and clinical stages.

Requirements for the Sr/Director of Regulatory Affairs:

• A bachelor’s and an advanced degree in life sciences, pharmacy, or a related field is preferred.
• 7+ years of regulatory affairs experience in the biopharmaceutical/biotech industry, with a substantial focus on gene therapy, cell therapy, or complex biologics.
• In-depth understanding of regulatory pathways for gene therapies, including INDs, BLA/MAA filings, orphan/expedited programs, and post-approval requirements.
• In-depth knowledge of FDA regulations, guidelines, and procedures relevant to drug development and clinical trials.
• Strong understanding of the drug development process, including preclinical, clinical, and regulatory requirements.
• Proven ability to develop and implement regulatory strategies.
• Strong communication and interpersonal skills, with the ability to effectively collaborate and influence cross-functional teams and build relationships with regulatory authorities.
• Detail-oriented with excellent organizational, project management, and problem-solving abilities.
• Ability to work in a fast-paced, dynamic startup environment and adapt to changing priorities and deadlines.

Responsibilities of the Sr/Director of Regulatory Affairs:

• Lead the development, execution, and oversight of global regulatory strategy that supports the company’s short- and long-term development goals across multiple therapeutic programs and modalities, including INDs, BLAs/NDAs/MAAs, and expedited pathways (e.g., Fast Track, RMAT, Orphan designations).
• Lead the preparation, submission, and management of IND applications and regulatory documentation for clinical trials, collaborating with a cross-functional team to ensure timely and high-quality submissions.
• Serve as the primary point of contact for regulatory agencies, fostering strong relationships and effectively communicating with regulatory authorities to address questions, provide necessary information, and resolve issues.
• Drive regulatory intelligence efforts, identifying risks, trends, competitive landscapes, and regulatory determinants that impact program decisions and product strategies.
• Develop mitigation plans and alternative pathways to avoid roadblocks and accelerate development milestones.
• Ensure regulatory guidance is applied across clinical, CMC, nonclinical, and translational activities, integrating emerging regulatory policy shifts and scientific expectations.