Amylyx Pharmaceuticals · 22 hours ago
Associate Director, Regulatory CMC
Cambridge, MA
Full-time
Hybrid
Lead/Staff, Director/Executive
$172K/yr - $194K/yr
8+ years expAmylyx Pharmaceuticals is a clinical-stage company focused on treating diseases with high unmet needs. They are seeking an Associate Director, Regulatory CMC who will be responsible for regulatory strategy and operations, ensuring compliance with regulatory requirements while collaborating with various internal and external teams.
BiotechnologyMedicalNeurosciencePharmaceutical
Responsibilities
Partners with cross-functional project teams to ensure regulatory timelines and strategies are developed and seamlessly executed upon, enabling successful filings with Global Health Authorities
Provide regulatory guidance on projects including regulatory strategy, requirements for clinical studies and marketing approval in domestic and international markets, strategic development plans (early and late-stage developments), and Health Authority interactions
Identify and communicate both regulatory and project risks, with potential solutions as needed
Lead/support Health Authority interactions related to CMC which includes briefing document preparation, coordination of meeting, preparations with subject matter experts, and documentation of minutes for projects that extend globally (United States, EU, and rest of world)
With minimal supervision, work with internal and external partners to manage assigned submission activities, including the preparation of routine correspondence, INDs/CTAs, BLAs/NDAs/MAAs, annual reports, IND/CTA amendments etc
Qualification
Required
Bachelor's degree in a scientific discipline or equivalent with a minimum of 8+ years relevant hands-on regulatory experience in pharmaceutical and/or biotechnology companies
Strong regulatory knowledge of global drug development within one or more therapeutic areas in early and late-stage development, including US/EU clinical trial requirements, manufacturing, and quality
Strong knowledge of drug development and regulatory policy
Demonstrated experience interacting with either the FDA or EMA is required
Demonstrated ability to successfully communicate verbally and in writing to convey complex information or obtain data across multiple disciplines and externally with partners including the FDA, international regulatory authorities, CROs is required
Proficient in pharmaceutical technical writing such as reports, and regulatory submissions is required as is experience reviewing technical documentation and reports
Position may require approximately 5-10% travel
Experience with US and ex-US clinical trial submissions
Preferred
Advanced life sciences degree preferred
Experience with orphan indication(s) working knowledge of accelerated pathways, Breakthrough designation, Fast Track designation, Priority Review, Orphan designation, and Priority Medicines Scheme (PRIME) designation
Company
Amylyx Pharmaceuticals
Amylyx Pharmaceuticals specializes in providing solutions for Alzheimer’s and other diseases of the brain.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$623.45MKey Investors
Viking Global InvestorsMorningside
2025-09-10Post Ipo Equity· $175M
2022-10-06Post Ipo Equity· $246.3M
2022-01-07IPO
Leadership Team
Jim Frates
Chief Financial Officer
Camille Bedrosian
Chief Medical Officer
Recent News
BioWorld Financial Watch
2026-01-11
Longevity.Technology
2026-01-11
Company data provided by crunchbase