Director, Regulatory Affairs

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:

The Director, Regulatory Affairs will be responsible for ensuring the delivery of science-based, solution-oriented, and globally aligned regulatory strategies for the assigned program(s). This role will provide regulatory guidance and support to cross-functional teams and will report to the Senior Vice President, Global Regulatory Affairs and Quality.

Responsibilities:

• Collaborate with key internal stakeholders to ensure the global regulatory strategy is incorporated and implemented within program deliverables. Develop and communicate to cross-functional teams, the program team, and senior leaders the immediate to long-range tactical plans to carry out established strategic objectives.
• Provide strategic regulatory perspective during the development, review, and approval of internal and external documentation to support the development and commercialization of assigned products, including clinical protocols, annual reports, initial Investigational New Drug applications / clinical trial applications and amendments, and regulatory agency meeting materials.
• Manage the content of global regulatory dossiers. Oversee regulatory agency submissions, with a quality focus to secure first-cycle approvals and authorizations. Ensure compliance with global regulatory requirements.
• Develop and maintain effective relationships with regulatory agency personnel and external regulatory experts / consultants to optimize regulatory outcomes. Proactively anticipate and mitigate regulatory risks.
• Research and analyze regulatory information; maintain current regulatory knowledge to keep abreast of regulatory procedures, changes, and trends. Provide relevant guidance and expertise to project/program teams.
• Provide guidance and support to study teams for regulatory aspects of clinical trials. Collaborate with CRO regulatory personnel and oversee activities in support of ex-US regulatory submissions.
• Demonstrate understanding of drug development and leadership behaviors consistent with level.
• Other duties as required.

• B.S or graduate degree in life sciences.
• Regulatory Affairs Certification preferred.
• 10 years of regulatory affairs experience in drug development and product registration activities within the biotech or pharmaceutical industry, with experience in multiple phases of development and within both small and large companies.
• Extensive experience with global regulatory processes, documents, and requirements (e.g., INDs, clinical trial applications, meeting request procedures and materials).
• Experience with small molecule drugs and across multiple therapeutic areas, including rare diseases.
• Full functional knowledge of regulatory requirements (directives, regulations, and guidance) pertaining to the development and registration of drug products in multiple ICH regions.
• Strategic thinking ability, strong organization and planning skills, and ability to communicate effectively and efficiently to multiple audiences.
• Demonstrated experience with regulatory programs for products to treat rare diseases and/or unmet medical needs (e.g., orphan designations, fast track, breakthrough therapy, PRIME).
• Proven leader with creative thinking ability; able to adapt and react to new information or changing priorities.
• Able to set priorities, work independently, and deliver results in a timely manner with excellent problem-solving skills and ability to make difficult judgment calls within sphere of responsibility.
• Ability to travel within the US and internationally as needed (less than 10% anticipated)