Senior Director, Regulatory Affairs​/CMC

Protego focuses on the discovery and development of first-in-class small molecule therapeutics that aim to reprogram protein folding for the treatment of various diseases. We are exploring monogenic protein misfolding diseases that cause myopathy, cardiomyopathy, stroke, renal disease, retinal diseases, channelopathies, and various degenerative diseases. Our approach builds on the proven pharmacological chaperones approach previously exemplified by tafamidis, which was discovered and developed by our cofounders Dr.

Jeffery W. Kelly and Dr. Richard Labaudinière, for the treatment of transthyretin amyloidosis.

About the job

Protego Therapeutics is seeking an experienced Senior Director, Regulatory Affairs (CMC) to join our small regulatory team. Reporting to the Senior Vice President of Regulatory Affairs, the Senior Director will own and execute the global CMC regulatory strategy as the company advances its lead AL amyloidosis program from proof-of-concept directly into a global pivotal study and on toward NDA/MAA submission.

This is a senior, hands-on role requiring deep small molecule CMC regulatory expertise and the judgment to operate as the company’s primary CMC regulatory voice with FDA and other global health authorities. The successful candidate will be equal parts strategist, author, and operator — setting the CMC regulatory strategy, personally driving submissions, managing CDMO and consultant partners, and building the CMC regulatory infrastructure that will carry the program through registration and beyond.

Primary Responsibilities

CMC Regulatory Strategy & Health Authority Engagement

• Own and execute the integrated global CMC regulatory strategy for Protego’s lead AL amyloidosis asset across proof-of-concept, pivotal, and registration phases, ensuring CMC readiness is never the rate-limiting step on the path to patients.
• Serve as Protego’s senior CMC regulatory point of contact with FDA and ex-US health authorities (EMA, MHRA, PMDA & NMPA), leading preparation, strategy, and delivery of Type B/C meetings, scientific advice, pre-NDA/pre-MAA interactions, and ad hoc agency engagements on CMC topics.
• Develop and execute strategies that leverage rare disease and expedited regulatory pathways — Orphan Drug Designation, Fast Track, Breakthrough Therapy, PRIME, and equivalent ex-US designations — to compress timelines without compromising data integrity.
• Anticipate CMC regulatory risk across the program (control strategy, starting material designation, impurity strategy, comparability, stability commitments, process validation strategy) and partner with the SVP and executive leadership to make informed, risk-balanced decisions.
• Provide CMC regulatory input into the target product profile (TPP) and integrated development plan.

CMC Submissions & Documentation

• Lead and personally author/oversee authoring of CMC content (Modules 2.3 and
  3) for INDs, IND amendments, CTAs/IMPDs, briefing books, annual reports, DSURs, orphan drug applications, and ultimately the NDA and MAA filings in eCTD format.
• Drive seamless proof-of-concept-to-pivotal CMC strategy, including phase-appropriate specifications, comparability protocols, process validation strategy, and registration stability program design.
• Coordinate and author CMC sections of agency briefing packages, designation applications, and responses to information requests.
• Establish and maintain a single source of truth for CMC submission content, ensuring consistency across regions and submission types as the program scales toward registration.

Cross-Functional Collaboration

• Partner with the CMC team, Quality, Analytical Development, Clinical, Nonclinical, and Program Management to align development plans, timelines, and risk-mitigation strategies with global CMC regulatory expectations.
• Provide senior regulatory input on CMC development decisions, including drug substance and drug product process development, scale-up, tech transfer, analytical method development and validation, container/closure, and lifecycle planning.
• Review and provide CMC regulatory input on clinical protocols, investigator brochures (IBs), and IND/CTA-supporting documentation.
• Influence and…