Orca Bio
Senior Director, Regulatory Affairs Lead
Menlo Park, CA · Director · Full-time
Sponsorship not specified$250k-$300kDetected 1 day ago
Project ManagementFDA RegulatoryPharmacovigilanceLeadershipCommunicationMentoringOrganizational SkillsRegulatory Affairs
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Lottery odds (Level IV)94
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About the role
- The Senior Director, Regulatory Affairs is Orca Bio's functional Head of Regulatory Affairs, leading the Regulatory Affairs function and serving as the company's primary regulatory subject-matter expert and advisor.
- Significant strategy decisions and major agency positions remain subject to executive leadership approval.
- Essential Duties & Key Responsibilities:
Responsibilities
- Develop and recommend regulatory strategy in partnership with executive leadership, and own execution of agreed strategic priorities across the organization.
- Provide ongoing compliance support for the commercialized product, including leading Regulatory Affairs review of labeling, promotional, advertising, and other commercial materials through the company's cross-functional review process.
- Partner closely with Clinical, CMC, Quality, Pharmacovigilance, and Commercial teams to execute regulatory deliverables supporting the commercialized product and broader pipeline, and maintain regulatory readiness for future development programs, new indications, global expansion, and other significant milestones.
- Maintain and continuously improve regulatory affairs systems, trackers, and records to ensure accurate, audit-ready documentation of submissions and commitments.
- Lead and develop the Regulatory Affairs team, and proactively keep executive leadership informed on regulatory status, risks, and timelines, bringing forward clear recommendations that foster accountability and continuous improvement.
Requirements
- Bachelor's degree in life sciences or a related discipline required.
- Working knowledge of drug development and commercialization requirements, including clinical trial requirements, CMC, manufacturing, quality, post-marketing surveillance, and promotional review.
- 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
Nice to have
- Track record of participating in approval of a commercial-stage product strongly preferred
- experience in hematology, oncology, cell therapy, or bone marrow transplant preferred.
Compensation
- Lead near-term post-approval regulatory execution, including commercial-stage supplements and variations, annual reports and lifecycle maintenance submissions, labeling updates, and post-marketing commitments.
- Demonstrated success managing post-approval regulatory activities, including commercial-stage supplements, labeling changes, annual reports, and post-marketing commitments.
Benefits
- Lead the assessment of significant regulatory, policy, and health-authority issues, providing executive leadership with clear recommendations, risks, and proposed paths forward.
- 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.
Company info
- We are driven by a passion for science and compassion for patients.
- We act with urgency to ensure our treatments are one day accessible to all who need them.
- We live by our core values of passion, courage, and integrity.
- Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
- We innovate on a path that hasn't been paved.
- We embrace an entrepreneurial spirit and take calculated risks to achieve our mission.
- We aren't afraid to ask "why not" and challenge the status quo.
- We maintain a start-up culture of camaraderie and leadership by example, regardless of title.
- We're proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.
- Notice to staffing firms Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening.
- Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only.
- We do not accept unsolicited resumes, and we rarely outsource recruitment.
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This listing is sourced directly from Orca Bio's careers page and normalized into a canonical job model.