Senior Manager, Regulatory Affairs, CMC

Stoke Therapeutics•Bedford, MA

1d•$181,000 - $213,000•Hybrid

About The Position

Stoke Therapeutics is a biotechnology company focused on restoring protein expression using RNA medicine. Their proprietary TANGO approach develops antisense oligonucleotides (ASOs) to restore natural protein levels. The company's first medicine, zorevunersen, is in Phase 3 trials for Dravet syndrome. Stoke's primary focus is on central nervous system and eye diseases caused by haploinsufficiency, with potential applications in other areas. The company is headquartered in Bedford, Massachusetts.

Requirements

BS/ BA degree in scientific, pharmaceutical or engineering discipline; advanced degree preferred
Minimum of 8 years of industry experience, including a minimum of 5 years directly in CMC Regulatory Affairs
Direct experience developing and implementing successful regulatory strategies in both US and EU markets
Direct experience with commercial phase programs and post-approval CMC requirements and implementation of regulatory milestones (e.g., Annual Reports)
Deep understanding of Module 3 sections and associated ICH, FDA, EMA regulations and guidance documents
Experience authoring Quality Modules 2.3 and 3; and health authority engagement content (e.g., FDA Briefing Books)
Practical experience in one of the following areas: manufacturing; process development; validation; analytical development, and/or quality.
Understanding of technical operations functions and systems including, but not limited to, technical risk assessments, change controls
Strong oral and written communication skills
Direct experience with Veeva RIM required

Nice To Haves

Combination Product and/or device experience
Global (beyond US, EU) regulatory experience
Working in complex and matrix environments
Oligonucleotide drug development

Responsibilities

Prepares and executes global regulatory CMC strategy for development programs and future commercial programs, including new applications, information amendments, annual reports, supplements/ variations, and responses to health authority questions.
Lead author, and able to collaborate with Subject Matter Experts, for Quality Modules. Effectively manage document review and approval workflows.
Analyzes and interprets technical information for impact to regulatory strategy and decisions.
Assesses change controls for regulatory impact and manages the implementation system for regulatory compliance.
Develops process(es) to track regulatory dossier lifecycle management, health authority questions, and post approval commitments, as needed.
Develops and implements documents, policies, and/or procedures for regulatory operational alignment and efficiencies.
Builds and maintains relationships within the Regulatory Affairs department and Technical Operations (CMC) teams.