About the Role
This role leads regulatory strategy and submission activities to support clinical development across multiple programs, ensuring alignment with global regulatory standards and timely approvals.
Responsibilities
- Lead preparation and submission of regulatory documents to global health authorities
- Develop regulatory strategies for product development and registration pathways
- Serve as primary regulatory liaison with health agencies during meetings and correspondence
- Ensure compliance with international regulatory requirements across regions
- Guide cross-functional teams on regulatory implications of development plans
- Oversee the creation of CTDs, INDs, NDAs, and other key submissions
- Monitor evolving global regulatory guidelines and adapt strategies accordingly
- Support clinical trial applications and regulatory approvals in multiple jurisdictions
- Provide regulatory input into protocols, protocols amendments, and study reports
- Coordinate responses to agency questions and deficiency letters
- Manage timelines for critical regulatory milestones
- Ensure proper labeling and claims are compliant with regulations
- Advise on regulatory requirements for new indications or formulations
- Support due diligence for partnerships or licensing opportunities
- Maintain regulatory intelligence systems to track agency decisions and trends
- Ensure regulatory documentation is archived and accessible per standards
- Train internal teams on regulatory updates and expectations
- Collaborate with CMC teams on chemistry, manufacturing, and controls sections
- Assist in development of pediatric study plans when applicable
- Work with external consultants and CROs on regulatory deliverables
- Prepare briefing packages for pre-IND and other regulatory meetings
- Ensure regulatory considerations are integrated early in R&D planning
- Support post-marketing regulatory obligations if applicable
- Oversee electronic submission formatting and delivery
- Contribute to agency inspection readiness efforts
Compensation
Competitive salary and comprehensive benefits package including equity incentives
Work Arrangement
Hybrid work model with combination of remote and on-site presence
Team
Part of a lean, agile drug development team focused on innovative therapeutics
About Us
We are a biopharmaceutical company focused on developing and commercializing innovative therapies to address public health challenges. Our pipeline includes candidates for central nervous system disorders, infectious diseases, and rare conditions. The company emphasizes scientific rigor, regulatory excellence, and patient-centered development.
Why Join Us?
Opportunity to shape regulatory strategy in a high-impact environment. Work closely with senior leadership and contribute to pivotal programs from early development through approval. Culture of innovation, accountability, and scientific integrity.
Not available for this position
