Associate Director, Regulatory CMC
Amylyx Pharmaceuticals
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.
Skills
Qualifications
About Amylyx Pharmaceuticals
amylyx.comAmylyx 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.
Recent company news
Yahoo FinanceAmylyx Pharmaceuticals Highlights Avexitide LUCIDITY Phase 3 Enrollment, Q3 Data Timing at Leerink Conf.
2 days ago
TipRanksAmylyx Pharmaceuticals Maps High-Stakes Path to 2027
2 days ago
Business WireAmylyx Pharmaceuticals to Participate in Upcoming March Investor Conferences
2 weeks ago
National TodayWall Street Zen Upgrades Amylyx Pharmaceuticals (NASDAQ:AMLX) Stock Rating
4 days ago
SahmThe Bull Case For Amylyx Pharmaceuticals (AMLX) Could Change Following Narrower Losses And New Shelf Filings
1 week ago
About Amylyx Pharmaceuticals
Headquarters
San Francisco, CA
Company Size
201-500 employees
Founded
2018
Industry
Technology
Glassdoor Rating
4.2 / 5
Leadership Team
Sarah Johnson
Chief Executive Officer
Michael Chen
Chief Technology Officer
Emily Williams
VP of Engineering
David Rodriguez
VP of Product
Jessica Thompson
Chief Financial Officer
Andrew Park
VP of Sales
Unlock Company Insights
View leadership team, funding history,
and employee contacts for Amylyx Pharmaceuticals.
Salary
$172k – $194k
per year
More jobs at Amylyx Pharmaceuticals
Similar Jobs
Senior Director, Regulatory Affairs CMC
Mirum Pharmaceuticals
Director, Global Regulatory Affairs (GRA) - CMC
Ironwood Pharmaceuticals
Associate Director, Regulatory CMC
Dyne Therapeutics
Senior Director, CMC Development, Biologics
Flagship Pioneering, Inc.
Senior Director, Regulatory Affairs CMC
Alcon
Director Regulatory Affairs, CMC
Bavarian Nordic