Associate Director, Regulatory CMC

Amylyx has an audacious mission to usher in a new era for treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. We are a clinical-stage company currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS).

Our mission is powered by our people. Our core values – be audacious, be curious, be authentic, be engaged, and be accountable – creating a culture of caring. Amylyx has assembled an experienced team ready to take action because the communities we serve have no time to wait. If you share our passion and are determined to tackle some of medicine’s toughest problems, we encourage you to read the opportunity below and apply.

The Opportunity

Amylyx Pharmaceuticals is looking for an Associate Director, Regulatory CMC who will be responsible for regulatory strategy and operations on identified projects, ensuring that Amylyx products comply with and meet regulatory requirements. This role works closely with internal and external teams from Supply Chain, Quality, Contract Manufacturing Organizations, as well as external consultants to advance the company’s portfolio. Responsibilities include representation on project teams, coordination and preparation of regulatory submissions, license renewals and annual registrations/updates as well as recommended changes to ensure continued compliance with applicable regulations.

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.

Required 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 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
• 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.

Work Location and Conditions

• At Amylyx, we proudly support remote work opportunities within the United States. However, due to business considerations related to health insurance coverage and state tax regulations, we are unable to hire employees who reside and/or work in certain states. Currently, we are not considering applicants from 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 and requested, which may include travel by air, driving or public transportation.
• You must have access to work in setting that meets all requirements of the role (including privacy, reliable internet access, phone, ability to communication via video co