Company Overview:
Contineum Therapeutics (Nasdaq: CTNM) is a clinical-stage biopharmaceutical company pioneering novel, oral small molecule therapies for NI&I indications with significant unmet need. Contineum is advancing a pipeline of internally-developed programs with multiple drug candidates now in clinical trials. PIPE-791 is an LPA1 receptor antagonist in clinical development for idiopathic pulmonary fibrosis and chronic pain. PIPE-307 is a selective inhibitor of the M1 receptor in clinical development for relapsing-remitting multiple sclerosis and major depressive disorder. For more information, please visit www.contineum-tx.com.
The Senior Director of Regulatory Affairs leads global regulatory activities and manages personnel for IND/CTA preparations, meetings, and maintenance to support new and ongoing development programs. This role reports to the Senior Vice President, Regulatory Affairs.
This role can be hybrid out of the San Diego office or fully remote for a candidate based on the West Coast of the United States with some travel to the San Diego office.
Job Summary
Key Responsibilities:
- Represent regulatory on study and program teams throughout study conduct and product development
- Prepare and/or review regulatory documents required for global product development (e.g. New IND/CTAs, DSURs, IND Amendments, health authority meetings and briefing documents, iPSP/PIP, NDA/MAA)
- Provide oversight of regulatory submissions vendor to assure technical accuracy, compliance, completeness, and timely regulatory agency submissions
- Lead development of global regulatory submissions, including requests from regulatory authorities relating to clinical trials, and responses to health authority requests for information, as required
- Manage and mentor direct reports to achieve department and corporate goals
- Provide regulatory support for company compliance initiatives, including SOP development, and documentation initiatives, etc.
- Review relevant clinical documents (protocol, informed consent form, investigator’s brochure, and site documentation, and required regulatory forms) for regulatory compliance
- Keep current on US and OUS regulations that apply to company products and processes