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 SummaryKey Responsibilities:Represent regulatory on study and program teams throughout study conduct and product developmentPrepare 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 submissionsLead development of global regulatory submissions, including requests from regulatory authorities relating to clinical trials, and responses to health authority requests for information, as requiredManage and mentor direct reports to achieve department and corporate goalsProvide 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 complianceKeep current on US and OUS regulations that apply to company products and processesRequirementsBachelor’s degree required; advanced degree preferred12+ years of experience in pharmaceutical/biotech, with minimum of 10 years of experience in regulatory affairs including clinical regulatory affairsExperience managing and mentoring direct reportsExperience with regulatory activities including creation of systems and processes to support efficient and high-quality submission of documents to regulatory bodiesAbility to translate regulatory requirements into practical achievable plansAbility to build strong relationships with co-workers of various backgrounds and expertiseDemonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environmentStrong organizational and multitasking skillsExcellent communication and interpersonal skillsAdditional Information: This position requires interaction with various regulatory authorities and adherence to relevant procedures and regulations.BenefitsWe offer a competitive total compensation package and work in a supportive team environment. The anticipated salary range for candidates who will work in San Diego, CA, is $240,000 - $265,000 annually. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Contineum offers competitive compensation and benefits, including:90% employer-covered benefitsFlexible PTOA very generous holiday schedule that includes a week off in August and time off around the winter holidaysA well-stocked kitchen with snacks and beveragesAdditional benefits include the opportunity for annual bonuses, stock options, an Employee Stock Purchase Program, and a 401(k) with an employer matchThe comprehensive wellness program includes medical, dental, vision, and LTD coverage
