BioPhase · 1 week ago
Director of Regulatory Affairs CMC
SD Metro Area
Full-time
Onsite
Director/Executive
$240K/yr - $250K/yr
10+ years expBioPhase is seeking a Director of Regulatory Affairs CMC to lead CMC regulatory strategy and execution in support of global clinical development programs. This role will oversee high-quality global regulatory submissions and lifecycle activities while providing strategic guidance on cross-functional CMC teams.
BiotechnologyPharmaceuticalRecruitingStaffing Agency
Hiring Manager
Ashley Teixeira, MSc.
Responsibilities
Serve as CMC regulatory lead, providing strategic guidance and regulatory oversight
Lead preparation, submission, and maintenance of INDs, CTAs, IMPDs, and related regulatory documents (e.g., DSURs, Investigator’s Brochures)
Manage global regulatory submissions and lifecycle activities, ensuring quality, compliance, and timely delivery
Collaborate cross-functionally to develop global CMC regulatory strategies and assess regulatory risks
Monitor evolving global regulations and provide regulatory intelligence and recommendations
Oversee external consultants, vendors, and regulatory timelines
Manage electronic trial master files (eTMF) for regulatory activities
Qualification
Required
Bachelor's degree in a scientific discipline
10+ years of experience in CMC Regulatory Affairs
Proven success authoring CMC sections of INDs and CTAs
Strong knowledge of FDA, ICH, and global regulatory requirements
Working knowledge of GMP, GLP, and GCP
Strategic, detail-oriented leader with strong communication and collaboration skills
Preferred
NDA/MAA experience preferred
ex-US experience a plus
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