Global Regulatory Strategy Lead – Oncology (Hybrid/Remote)

Regulatory Jobs; San Diego (CA); Hybrid; USD 230,000 - 300,000; Full time

Benefits offered by this job

Annual bonus program

Incentive stock option plan

401k plan with employer contribution

Comprehensive medical insurance

Dental and vision insurance

HSA, FSA, and supplemental plans

Unlimited PTO

Generous holiday schedule

Relocation assistance

Job summary

Janux Therapeutics, Inc. is seeking a Senior Director, Global Regulatory Affairs to provide strategic regulatory leadership for early- and late-stage oncology programs.

The role involves coordinating global regulatory strategies, interacting with health authorities, and guiding cross-functional development plans within a fast-paced environment. The ideal candidate has 12–15+ years in biotech/pharma regulatory affairs, experience with IND/CTA submissions (EU CTR), and proven leadership across

Qualifications

• BS in life sciences or related field required; advanced degree preferred.
• 12–15+ years regulatory affairs in biotech/pharma.
• Experience spanning early development through global regulatory strategy for oncology.
• Direct experience with IND and global CTA submissions, including EU CTR.
• Proven track record with health authority interactions (FDA and ex-US).
• Ability to operate in uncertain, shifting priorities with incomplete data.
• Strong leadership and ability to influence multiple functions without direct authority.
• Excellent communication and executive presence for senior stakeholders.

Responsibilities

• Lead global regulatory strategies across early- and late-stage programs.
• Translate plans into practical regulatory execution with cross-functional teams.
• Serve as regulatory lead on program teams, ensuring timely decisions.
• Influence trial design, endpoints, and development pathways.
• Lead IND/CTA planning and health authority engagement.
• Interact with global health authorities, including meetings and filings.
• Identify regulatory risks and mitigation strategies in evolving data contexts.
• Collaborate with internal teams and external partners to ensure timely deliverables.

Skills

Regulatory strategy

Health authority negotiations

IND/CTA submissions

Cross-functional leadership

FDA/EMA interactions

Development strategy

Education

BS in life sciences

Advanced degree preferred

Job description

Janux Therapeutics, Inc. is seeking a Senior Director, Global Regulatory Affairs to provide strategic regulatory leadership for early- and late-stage oncology programs.

The role involves coordinating global regulatory strategies, interacting with health authorities, and guiding cross-functional development plans within a fast-paced environment. The ideal candidate has 12–15+ years in biotech/pharma regulatory affairs, experience with IND/CTA submissions (EU CTR), and proven leadership across