Surf Search · 18 hours ago
Director of Regulatory Affairs
United States
Full-time
Remote
Senior Level, Lead/Staff, Director/Executive
$200K/yr - $240K/yr
7+ years expSurf Search is a small, clinical-stage startup developing immunotherapies for cancer. They are seeking a Sr. or Director of Regulatory Affairs to lead regulatory strategy and drive the successful development of therapeutic candidates through preclinical and clinical stages.
Staffing & Recruiting
Hiring Manager
Siena Burwell
Responsibilities
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
Qualification
Required
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
Preferred
A bachelor's and an advanced degree in life sciences, pharmacy, or a related field is preferred
Company
Surf Search
As a boutique firm, we are able to take the time to understand our clients and their business.
2-10 employees
Funding
Current Stage
Early StageLeadership Team
Debbie Winkelbauer
CEO | (800) 713-3532 | dwink@surfsearch.org
Jan Hudson
COO | 800.713.3532 | www.surfsearch.org
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