Senior Director, Regulatory Affairs

Contineum Therapeutics

Senior Director of Regulatory Affairs leading global regulatory activities for biopharmaceutical company. Overseeing IND/CTA preparations and managing personnel with a focus on compliance and submissions.

Posted 5/4/2026full-timeSan Diego • California • 🇺🇸 United StatesSenior💰 $240,000 - $265,000 per yearWebsite

About the role

Key responsibilities & impact

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

Requirements

What you’ll need

Bachelor’s degree required; advanced degree preferred
12+ years of experience in pharmaceutical/biotech, with minimum of 10 years of experience in regulatory affairs including clinical regulatory affairs
Experience managing and mentoring direct reports
Experience with regulatory activities including creation of systems and processes to support efficient and high-quality submission of documents to regulatory bodies
Ability to translate regulatory requirements into practical achievable plans
Ability to build strong relationships with co-workers of various backgrounds and expertise
Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment
Strong organizational and multitasking skills
Excellent communication and interpersonal skills

Benefits

Comp & perks

90% employer-covered benefits
Flexible PTO
A very generous holiday schedule that includes a week off in August and time off around the winter holidays
A well-stocked kitchen with snacks and beverages
Additional benefits include the opportunity for annual bonuses, stock options, an Employee Stock Purchase Program, and a 401(k) with an employer match
The comprehensive wellness program includes medical, dental, vision, and LTD coverage

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Hard Skills & Tools

regulatory submissionsIND/CTAsDSURsNDA/MAAclinical regulatory affairsSOP developmentregulatory complianceregulatory documentsclinical trialsregulatory activities

Soft Skills

mentoringrelationship buildingorganizational skillsmultitaskingcommunication skillsinterpersonal skillsleadershipgoal achievementdeadline managementpractical planning

Certifications

Bachelor's degreeadvanced degree