Associate Director, Regulatory CMC

Role Summary

Associate Director, Regulatory CMC responsible for regulatory strategy and operations on identified projects, ensuring Amylyx products comply with and meet regulatory requirements. This role collaborates with internal teams (Supply Chain, Quality, Contract Manufacturing Organizations) and external consultants to advance the portfolio. You will represent the regulatory function on project teams, coordinate and prepare regulatory submissions, license renewals and annual registrations, and propose changes to maintain ongoing compliance with applicable regulations.

Responsibilities

• Partners with cross-functional project teams to ensure regulatory timelines and strategies are developed and executed, 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 regulatory and project risks, with potential solutions as needed.
• Lead/support Health Authority interactions related to CMC including briefing document preparation, coordination of meetings, preparations with subject matter experts, and documentation of meeting minutes for projects that extend globally (United States, EU, and rest of world).
• With minimal supervision, work with internal and external partners to manage submission activities, including the preparation of routine correspondence, INDs/CTAs, BLAs/NDAs/MAAs, annual reports, IND/CTA amendments, etc.

Qualifications

• 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; advanced life sciences degree preferred.
• 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 communicate verbally and in writing to convey complex information 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; experience reviewing technical documentation and reports.
• Position may require approximately 5-10% travel.
• Experience with US and ex-US clinical trial submissions.
• Experience with orphan indications, and working knowledge of accelerated pathways, Breakthrough designation, Fast Track designation, Priority Review, Orphan designation, and PRIME designation.

Additional Requirements

• Remote work opportunities within the United States are supported; however, due to health insurance coverage and state tax regulations, we are unable to hire employees who reside and/or work in certain states (Alaska, Arizona, Hawaii, Michigan and Tennessee).
• You will be expected to travel to our corporate location in Cambridge, MA several times a year and attend other company-related events as necessary, which may include travel by air, driving or public transportation.
• You must have access to a work setting that meets all requirements of the role (privacy, reliable internet access, phone, and ability to communicate via video conference) at your remote location.