Senior Director, Global Regulatory Strategy – Oncology

Tyra Biosciences; Stati Uniti; In loco; USD 275.000 - 303.000; Tempo pieno

Vantaggi offerti da questo lavoro

Competitive compensation package

Equity opportunity

Medical, dental, and vision insurance

401(k) with company match

Paid time off and holidays

Descrizione del lavoro

Tyra Biosciences is seeking a Senior Director of Regulatory Affairs, Oncology to lead global regulatory strategies for late-stage oncology programs in a fast-growing biotech setting.

The role requires extensive experience with global submissions, health authority interactions, and cross-functional leadership to accelerate registration and lifecycle management in major markets, with up to 20% travel.

Competenze

• Bachelor’s degree in a scientific discipline; advanced degree strongly preferred.
• 10+ years of progressive global regulatory strategy experience in biotech/pharma.
• Led late-stage development and global registration for oncology products.
• Experience with major global marketing applications (NDA/BLA/MAA) and health authority interactions.

Mansioni

• Develop and execute global regulatory strategies for a late-stage oncology program.
• Lead regulatory strategy from late-stage development through submissions, approvals, and lifecycle management.
• Engage with global health authorities (FDA, EMA, PMDA, MHRA, Health Canada) and prepare for regulatory meetings.
• Support accelerated or innovative regulatory pathways in oncology.
• Provide regulatory leadership to cross-functional oncology program teams and ensure compliant plans.

Conoscenze

Global regulatory strategy

Oncology expertise

FDA/EMA interactions

Leadership & mentoring

Formazione

Bachelor’s degree in science

Advanced degree preferred (MS/PhD/MD/PharmD)

Descrizione del lavoro

Tyra Biosciences is seeking a Senior Director of Regulatory Affairs, Oncology to lead global regulatory strategies for late-stage oncology programs in a fast-growing biotech setting.

The role requires extensive experience with global submissions, health authority interactions, and cross-functional leadership to accelerate registration and lifecycle management in major markets, with up to 20% travel.