What are the responsibilities and job description for the Vice President Regulatory Affairs position at BioPhase?
Executive Director or Vice President, Regulatory Affairs
Onsite in San Diego, CA.
Direct Hire
Comp : 280k - 350k DOE
A senior leadership position requiring expertise in shaping regulatory approaches and fostering relationships with internal teams and global regulatory agencies (e.g., FDA, EMA). This role involves steering strategic initiatives, enhancing operational practices, and implementing essential policies. Additional responsibilities include overseeing clinical trial design, regulatory submissions, and team development, reporting directly to the organization’s top executive.
Primary Duties
- Develop and guide regulatory strategies for clinical development, with a focus on niche therapeutic areas.
- Partner with clinical teams to create and execute market readiness plans.
- Oversee preparation and submission of regulatory documents, including INDs and NDAs.
- Lead and mentor a high-performing regulatory team, establishing robust processes.
- Implement operational standards for submission procedures and internal compliance policies.
Ideal Candidate Profile
