Senior Director, Regulatory Affairs

Orca

. Lead Orca Bio's Regulatory Affairs function and serve as the company's senior regulatory leader.

Posted 9/23/2026full-timeRemote • California • United StatesSenior💰 $250,000 - $300,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Expertise in Regulatory Affairs with a focus on U.S. and global health authority engagement, post-approval regulatory activities, and compliance support for commercialized products. Proven leadership in developing high-performing teams and executing regulatory strategies in the biotechnology or pharmaceutical industry.

Highest-signal resume keywords

Regulatory Affairs LeadershipPost-Approval Regulatory ActivitiesU.S. Regulatory ExperienceTeam Development and CoachingCommunication and Project Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Strategy DevelopmentLifecycle PlanningCommercial-Stage SupplementsLabeling ChangesAnnual ReportsPost-Marketing CommitmentsDrug Development KnowledgeClinical Trial RequirementsCMC and ManufacturingQuality Compliance

Soft Skills

Excellent Written CommunicationExcellent Verbal CommunicationOrganizational SkillsDetail-OrientedProactive Engagement

Tools & Technologies

Regulatory Affairs SystemsAudit-Ready Records

Industry Keywords

BiotechnologyPharmaceuticalFDAEMAHematologyOncologyCell TherapyBone Marrow TransplantHealth-Authority EngagementPost-Marketing Surveillance

About the role

Key responsibilities & impact

Lead Orca Bio's Regulatory Affairs function and serve as the company's senior regulatory leader.
Advise the C-Suite and executive leadership on regulatory strategy, health-authority engagement, lifecycle planning, risks, and emerging requirements.
Develop and recommend regulatory strategy with executive leadership and execute agreed strategic priorities.
Lead post-approval regulatory execution, including commercial-stage supplements and variations, annual reports, lifecycle maintenance submissions, labeling updates, and post-marketing commitments.
Provide compliance support for the commercialized product, including Regulatory Affairs review of labeling, promotional, advertising, and other commercial materials.
Lead interactions and correspondence with the FDA, EMA, and other health authorities.
Partner with Quality on inspections, regulatory commitments, and follow-up actions.
Assess significant regulatory, policy, and health-authority issues and provide recommendations to executive leadership.
Partner with Clinical, CMC, Quality, Pharmacovigilance, and Commercial teams on regulatory deliverables and pipeline readiness.
Maintain and improve regulatory affairs systems, trackers, and audit-ready records.
Lead and develop the Regulatory Affairs team and keep executive leadership informed on status, risks, and timelines.

Requirements

What you’ll need

Bachelor’s degree in life sciences or a related discipline required.
10+ years of regulatory affairs experience in the biotechnology or pharmaceutical industry, including deep U.S. regulatory experience and meaningful experience working with global health authorities such as the EMA.
Demonstrated success managing post-approval regulatory activities, including commercial-stage supplements, labeling changes, annual reports, and post-marketing commitments.
Working knowledge of drug development and commercialization requirements, including clinical trial requirements, CMC, manufacturing, quality, post-marketing surveillance, and promotional review.
Proven people leader with a track record of building, coaching, and developing high-performing teams.
Excellent written and verbal communication skills, with the ability to proactively engage and inform executive leadership and translate complex regulatory matters into clear, actionable recommendations; strong project management and organizational skills suited to a hands-on, detail-oriented, small commercial-stage biotech environment.
Track record of participating in approval of a commercial-stage product strongly preferred; experience in hematology, oncology, cell therapy, or bone marrow transplant preferred.

Benefits

Comp & perks

Pre-IPO equity
Annual bonus
Medical benefits
Dental benefits
Vision benefits
PTO
401(k) plan
Life and accidental death and disability coverage
Parental leave benefits
Subsidized daily lunches and snacks at on-site locations