BioPhase · 5 days ago
Vice President of Regulatory Affairs
San Diego, CA
Full-time
Onsite
Director/Executive
$350K/yr - $400K/yr
10+ years expBioPhase is seeking a Vice President of Regulatory Affairs who will oversee global regulatory planning and execution for development programs. This role involves shaping regulatory pathways, guiding interactions with health authorities, and ensuring compliance with organizational objectives through effective regulatory strategy and operations.
BiotechnologyPharmaceuticalRecruitingStaffing Agency
Hiring Manager
Kendall Strahl
Responsibilities
Lead regulatory strategy and operations for both U.S. and international filings throughout the product development life cycle, ensuring submissions are timely, high quality, and supportive of corporate priorities
Serve as the regulatory voice across cross-functional project teams, advising on requirements, risks, and next steps for clinical, CMC, and nonclinical programs
Prepare, review, and maintain key regulatory submissions and supporting dossiers (e.g., INDs, CTAs, briefing packages, annual updates, and related amendments), and support compilation of clinical and regulatory source documents such as protocols, investigator brochures, and study reports
Coordinate global regulatory strategy to enable alignment across development workstreams
Monitor evolving regulatory expectations and communicate implications to leadership and project teams
Oversee external consultants, contractors, and vendors supporting regulatory activities
Establish and drive regulatory submission timelines and deliverables
Support maintenance of electronic regulatory and clinical documentation systems as needed for development and submission activities
Qualification
Required
Advanced degree in a scientific or medical field (e.g., PharmD, PhD, MD, MS) with 10+ years of experience within biotechnology, pharmaceuticals, or a regulatory authority; at least 5 years focused specifically on regulatory affairs
Direct experience leading regulatory engagements with U.S. and ex-U.S. health agencies, including negotiation and facilitation of meetings to drive development forward
Demonstrated track record with early-stage and/or late-stage submissions such as INDs (required) and NDAs or comparable marketing applications (preferred), including hands-on familiarity with CTD/eCTD structure and publishing
Strong working knowledge of GXP regulations and the drug development life cycle
Solid understanding of FDA, ICH, and international regulatory frameworks
Proficiency with standard business and communication software tools
Excellent writing, editing, and document quality control abilities
Strong analytical and problem-solving capabilities with collaborative working style
Ability to manage multiple priorities, adapt to changing conditions, and operate with professionalism and attention to detail
Self-directed, reliable, and comfortable in a fast-moving environment
Effective communicator with strong interpersonal skills and team orientation
Preferred
NDA or comparable marketing applications
Company
BioPhase
BioPhase Solutions specializes in staffing and recruiting professionals for pharmaceutical, biotech and medical device companies.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase