Director, Regulatory Affairs CMC

Description

Sionna Therapeutics is a clinical-stage biopharmaceutical company on a mission to revolutionize the current treatment paradigm for CF by developing novel medicines that normalize the function of the CFTR protein. Sionna’s goal is to deliver differentiated medicines for people living with CF that can restore their CFTR function to as close to normal as possible by directly stabilizing CFTR’s nucleotide-binding domain 1 (NBD1), which the company believes is central to potentially unlocking meaningful improvements in clinical outcomes and quality of life for people with CF. Leveraging over a decade of the co-founders’ extensive research on NBD1, the company is advancing a pipeline of novel small molecules engineered to correct the defects caused by the F508del genetic mutation, which resides in NBD1. Sionna is also developing a portfolio of complementary CFTR modulators that are designed to work synergistically with its NBD1 stabilizers to improve CFTR function.

Position Summary:

Sionna Therapeutics is seeking an experienced individual to provide strategic and hands-on support for our evolving clinical-stage pipeline. This individual will work closely with the CMC, Quality Assurance, Clinical Drug Supply, and Regulatory Affairs teams to ensure the successful planning, development, and delivery of CMC regulatory strategy across programs. 

The ideal candidate brings deep expertise in CMC regulatory execution for mid- to late-stage clinical development, exceptional scientific writing ability, and the ability to operate independently in a dynamic, fast-moving environment. 

Responsibilities:

Regulatory Writing & Submission Support 

• Coordinate submission and information request response timelines and completion. 
• Author and/or review CMC sections of regulatory submissions for global clinical trial applications, including IND amendments, CTAs, IMPDs, and annual reports in collaboration with subject matter experts.  
• Translate complex technical data into clear, concise, and compliant regulatory language. 
• Prepare responses to CMC-related health authority questions in coordination with CMC and Quality subject matter experts. 
• Ensure documents meet formatting, accuracy, completeness, and submission-ready standards. 

CMC Regulatory Strategy & Planning 

• Contribute to CMC regulatory strategy for ongoing and upcoming development activities, providing risk assessments, mitigation recommendations, and scenario planning. 
• Support strategic considerations around manufacturing process changes, analytical method evolution, comparability planning, stability strategies, and supply-chain readiness. 
• Collaborate closely with CMC, Quality, and Clinical Drug Supply to align regulatory expectations with operational plans and program timelines. 

Cross-Functional Collaboration 

• Serve as a key regulatory partner to CMC, QA, and Clinical Drug Supply teams. 
• Participate in cross-functional project discussions to identify regulatory implications of technical decisions. 
• Ensure consistent communication of regulatory requirements, precedents, and expectations across technical teams. 

Regulatory Intelligence & Compliance 

• Monitor relevant FDA, EMA, ICH, and other global CMC regulations and guidance to ensure strategies remain current and compliant. 
• Identify evolving regulatory trends and interpret their impact on development plans. 
• Promote best practices in documentation quality, change control, and regulatory readiness. 

Requirements

•  Bachelor’s degree in a scientific discipline required; advanced degree (MS, PhD, PharmD) preferred. 
• 12+ years of Regulatory Affairs experience, with significant hands-on Regulatory CMC leadership across the product lifecycle, from clinical development through registration, marketing authorization, and post-approval activities. 
• Proven experience preparing and reviewing CMC components of investigational and marketing applications for novel small molecule therapeutics (new chemical entities) intended for oral administration. 
• Experience participating in and/or directing CMC-focused meetings with health authorities, including leading internal team to identify and develop questions for agency input; author, review, and submit briefing materials; and facilitate meeting discussion to obtain desired outcomes. 
• Experience leading CMC activities for NDA and MAA submissions, including development and management of timelines, guiding discussions of regulatory strategy for submission content, and collaborating with stakeholders to support inspection readiness. 
• Strong understanding of global CMC regulatory requirements (FDA, EMA, ICH). 
• Demonstrated ability to interpret and translate manufacturing, analytical, and quality data into clear regulatory documentation. 
• Experience working closely with internal and external stakeholders as required. 
• Excellent communication, organizational, and technical writing skills; ability to multitask and work independently. 
• Ability to operate effectively as a technical business partner, prioritizing work across multiple deliverables with minimal oversight.  
• Experience working within Veeva (Quality, RIM). 
• Strategic thinker with strong attention to detail and the ability to execute efficiently. 
• Collaborative and solutions-oriented partner who builds strong cross-functional relationships. 
• Ability to leverage experience, strategic insight, and creative thinking to develop and evaluate multiple solutions to complex business challenges. 
• Comfortable operating in a fast-paced, resource-lean, clinical-stage biotech environment. 
• Flexible, proactive, and able to adapt to evolving priorities and timelines. 

Salary Range: $200,000 - $240,000