Manager, Regulatory Affairs, CMC
Stoke Therapeutics
Summary
The Regulatory CMC Manager is responsible for contributing to the development of Stoke's products by supporting global CMC regulatory strategies, leading lifecycle management initiatives, and providing regulatory guidance to cross-functional teams for multiple programs. This position will report to the Director of Regulatory CMC.
Job description
Position Purpose
The Regulatory CMC Manager is responsible for contributing to the development of Stoke's products by supporting global CMC regulatory strategies, leading lifecycle management initiatives, and providing regulatory guidance to cross-functional teams for multiple programs. This position will report to the Director of Regulatory CMC.
Key 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.
Required Skills & Experience
- 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.
Preferred Experience
- Combination Product and/or device experience.
- Global (beyond US, EU) regulatory experience.
- Working in complex and matrix environments.
- Oligonucleotide drug development.
Requirements
- BS/BA degree in scientific, pharmaceutical or engineering discipline
- Minimum of 8 years of industry experience
- Minimum of 5 years directly in CMC Regulatory Affairs
- Direct experience developing and implementing regulatory strategies in US and EU markets
- Direct experience with commercial phase programs and post-approval CMC requirements
- Deep understanding of Module 3 sections and ICH, FDA, EMA regulations
- Experience authoring Quality Modules 2.3 and 3 and health authority engagement content
- Practical experience in manufacturing, process development, validation, analytical development, and/or quality
- Understanding of technical operations functions including technical risk assessments and change controls
- Strong oral and written communication skills
- Direct experience with Veeva RIM
Benefits
- Medical, Dental & Vision
- Life Insurance
- Long & Short-Term Disability
- Paid Parental Leave
- 401(k) Matching
- Unlimited PTO
- Tuition Assistance
- Employee Stock Purchase Program
- Annual Bonus
- Equity Participation
Company overview
Stoke Therapeutics (Nasdaq: STOK) is a biotechnology company dedicated to developing novel RNA-based medicines for severe genetic diseases. Founded in 2014 and headquartered in Bedford, Massachusetts, the company employs its proprietary TANGO (Targeted Augmentation of Nuclear Gene Output) approach to create antisense oligonucleotides (ASOs) that selectively restore naturally-occurring protein levels. Stoke's innovative platform focuses on haploinsufficiency diseases where patients have approximately 50% of normal protein levels, primarily targeting conditions affecting the central nervous system and eyes. The company's lead investigational medicine, zorevunersen (STK-001), is currently in Phase 3 clinical trials for Dravet syndrome, a severe form of childhood epilepsy, and has demonstrated promising disease-modifying potential. Stoke also has preclinical programs including STK-002 for autosomal dominant optic atrophy. The company has established strategic collaborations with industry leaders like Biogen for Dravet syndrome development and Acadia Pharmaceuticals for neurodevelopmental disorders. With approximately 51-200 employees, Stoke Therapeutics represents a pioneering force in RNA medicine, aiming to address unmet medical needs in rare genetic diseases through its innovative protein restoration technology.