VP Regulatory Affairs & Quality for Oncology (Hybrid)

Dennis Partners; San Francisco (CA); Hybrid; USD 351.000 - 388.000; Vollzeit

Benefits dieser Stelle

Hybrid work arrangements

Zusammenfassung

Dennis Partners seeks a VP of Regulatory and Quality to lead global regulatory and quality for a portfolio of oncology programs. The role partners with the COO and interfaces with health authorities, guiding IND/CTA strategy and submissions.

This hybrid Bay Area position requires 15+ years in regulatory affairs with senior leadership experience and a track record of advancing early- and mid-stage oncology assets through regulatory milestones.

Qualifikationen

• 15+ years of progressive, relevant experience in Regulatory Affairs within biotech/pharma.
• Must have strong oncology drug development experience (10+ years).
• Experience across all development phases from pre-IND to post-approval.

Aufgaben

• Develop and execute global regulatory strategy for oncology programs across development lifecycle.
• Lead regulatory filings (INDs/CTAs) and briefing documents with cross-functional teams.
• Serve as primary agency contact with FDA and other health authorities.
• Advise on regulatory pathways and designations and their trial design implications.
• Oversee Quality with a risk-based QMS covering GLP, GCP, GVP and GMP.
• Lead audits of CROs/CMOs and manage quality agreements with partners.
• Develop quality metrics and dashboards to identify compliance risks.
• Guide safety governance input for labeling, publications, and disclosures.
• Own departmental planning, budgeting, and system requirements for scale.
• Coach and develop direct reports in a lean Phase 1/2 setting.

Kenntnisse

Regulatory leadership

Regulatory strategy

FDA interactions

Oncology drug development

Global regulatory

Quality leadership

GXP knowledge

Vendor oversight

Cross-functional collaboration

Strategic planning

Executive stakeholder management

Travel readiness

Ausbildung

Bachelor's degree in life sciences

Advanced degree (MS/PhD/PharmD)

Jobbeschreibung

Dennis Partners seeks a VP of Regulatory and Quality to lead global regulatory and quality for a portfolio of oncology programs. The role partners with the COO and interfaces with health authorities, guiding IND/CTA strategy and submissions.

This hybrid Bay Area position requires 15+ years in regulatory affairs with senior leadership experience and a track record of advancing early- and mid-stage oncology assets through regulatory milestones.