Senior Director, Global Regulatory Strategy — Rare Diseases

Denali Therapeutics; South San Francisco (CA); Sur place; USD 269 000 - 350 000; Plein temps

Avantages offerts par ce poste

401k

Healthcare coverage

ESPP

Résumé du poste

Denali Therapeutics is seeking a Senior Regulatory Strategist to lead global regulatory strategy for its rare disease and CNS biologics portfolio, from IND/CTA through BLA/MAA and lifecycle management.

You will interact with FDA, EMA, and PMDA, shape endpoints and trial design, and drive expedited pathways, while building and guiding a team of Global Regulatory Leads to align with corporate objectives.

Qualifications

• Bachelor’s degree in life sciences; advanced degree preferred.
• 15+ years biopharma regulatory affairs with 7+ years in a senior management role.
• Proven track record leading FDA/EMA interactions and marketing applications (BLA/MAA).
• Deep knowledge of US/EU/Japan biologics regulations with rare disease focus.

Responsabilités

• Leads global regulatory strategy for rare disease portfolio from IND/CTA through BLA/MAA and lifecycle management.
• Represents Clinical Regulatory Affairs - Rare Diseases to executive leadership and Board on regulatory strategy, risk, and options.
• Direct engagement for major Health Authority interactions (FDA types, EMA advice, PMDA) including endpoints and trial design discussions.
• Drives strategy for expedited pathways (Breakthrough, RMAT, Fast Track, Accelerated Approval, Orphan).
• Builds and leads a team of Global Regulatory Leads and ensures governance frameworks are followed.

Connaissances

Regulatory leadership

FDA/EMA interactions

Biologics regulation

Rare disease regulatory

Cross-functional leadership

Strategic thinking

Executive communication

Formation

Bachelor's degree in life sciences

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

Outils

AI regulatory tools

Description du poste

Denali Therapeutics is seeking a Senior Regulatory Strategist to lead global regulatory strategy for its rare disease and CNS biologics portfolio, from IND/CTA through BLA/MAA and lifecycle management.

You will interact with FDA, EMA, and PMDA, shape endpoints and trial design, and drive expedited pathways, while building and guiding a team of Global Regulatory Leads to align with corporate objectives.