Associate Director, Regulatory CMC

Amylyx Pharmaceuticals(8 hours ago)

HybridFull TimeDirector$172,000 - $194,000Regulatory Affairs

About this role

The Associate Director, Regulatory CMC at Amylyx Pharmaceuticals leads regulatory strategy and operations for CMC activities to advance the company’s clinical-stage product portfolio. This role coordinates with internal teams and external partners to ensure products meet global regulatory requirements and supports regulatory interactions and submissions across major health authorities. The position supports program advancement across early and late-stage development while enabling cross-functional alignment.

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Required Skills

Regulatory Strategy
CMC
Submissions Management
Health Authorities
Technical Writing
Project Leadership
Risk Identification
Clinical Submissions
Manufacturing Compliance

Qualifications

Bachelor's Degree in Scientific Discipline
Advanced Degree Preferred

About Amylyx Pharmaceuticals

amylyx.com

Amylyx is a biopharmaceutical company focused on developing treatments for progressive neurodegenerative diseases. Its lead therapy, AMX0035 (marketed as Relyvrio), is a combination treatment for ALS designed to protect neurons by targeting mitochondrial and endoplasmic reticulum dysfunction. Amylyx advances a pipeline testing similar neuroprotective approaches in other neurological disorders and runs clinical trials to generate patient-centered evidence. The company emphasizes translational research, regulatory engagement, and partnerships with patients and clinicians to bring new therapies to market.