SVP of Regulatory and Quality

About us:

Ascidian is redefining the treatment of disease by rewriting RNA.

Ascidian Therapeutics was founded to rewrite RNA by editing and replacing human exons. We were inspired by ocean creatures, called Ascidians, who are primordial ancestors of vertebrates. To grow from larvae to adults, ascidians re-engineer their transcriptome through RNA editing via trans-splicing and alternative splicing.

In our Brighton/Boston labs, RNA biology meets today’s cutting-edge genomics, computational biology, and deep-sequencing technologies to create a new class of medicines that address the underlying causes of disease. We welcome you to come join our vibrant team and help us lead the way into a new gene therapy era.

Who are we looking for?

As a key member of the executive team, the Senior Vice President (SVP) of Regulatory Affairs, and Quality will play a pivotal leadership role in leading our regulatory affairs and quality assurance function with distinction, integrity, and strategic foresight.  You will be responsible for developing and implementing robust regulatory strategies that align with our business objectives, ensuring timely regulatory submissions, fostering and maintaining strong relationships with the FDA and other international regulatory agencies, and fostering a culture of quality excellence accountability and continuous improvement throughout the organization. Additionally, you will oversee the optimization of our quality management systems, driving efficiencies, mitigating risks to safeguard our reputation, and navigating complex regulatory landscapes for RNA exon editing programs.

Key Responsibilities:

• Regulatory Strategy Development:
• Lead the development and execution of regulatory strategies for our RNA exon editing programs, ensuring alignment with the FDA, and global regulatory requirements, if needed.
• Oversee the preparation, submission, and maintenance of regulatory filings, including INDs, BLAs, NDAs, and other submissions required for gene therapy products.
• Ensure that all regulatory submissions meet high-quality standards and are in compliance with evolving regulations.
• Quality Assurance & Compliance:
• Lead the Quality Assurance (QA) and Compliance functions, ensuring that RNA exon editing products meet all regulatory standards from clinical development through commercialization.
• Oversee the development, implementation, and maintenance of Quality Management Systems (QMS), ensuring compliance with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP).
• Ensure that all activities across product development, manufacturing, and clinical trials meet or exceed regulatory requirements and quality standards.
• Regulatory and Quality Audits:
• Lead and manage regulatory inspections and audits, including FDA inspections, ensuring preparedness, compliance, and successful outcomes.
• Develop and implement corrective and preventive actions (CAPAs) following audits, and ensure timely follow-up on all audit findings.
• Regulatory Agency Engagement:
• Serve as the primary liaison with the FDA and other regulatory bodies, ensuring clear communication and fostering positive relationships.
• Lead regulatory agency meetings (e.g., pre-IND, end-of-phase, pre-BLA meetings) and participate in advisory committee interactions.
• Act as the company's spokesperson for regulatory matters, ensuring transparency and trust with external stakeholders.
• Risk Management:
• Identify and manage regulatory and quality risks, providing strategic guidance on mitigation approaches throughout the gene therapy product lifecycle.
• Develop and maintain compliance monitoring programs to ensure adherence to regulations and internal policies.
• Global Regulatory and Quality Support:
• Provide support for global regulatory submissions and compliance efforts, working with international regulatory leads to facilitate product approvals in major markets.
• Ensure global quality standards are met, implementing consistent quality systems and regulatory approaches worldwide.
• Regulatory and Compliance Intelligence:
• Stay abreast of evolving regulations, industry trends, and best practices in the gene therapy, editing, genetic medicine, and biotechnology sectors, providing proactive advice to the company on regulatory, quality, and compliance matters.

Qualifications:

• PhD/PharmD/MD in a scientific discipline
• 15+ years of experience in regulatory affairs, with 6 years in gene therapy, gene editing, or RNA therapeutics, including significant exposure to quality assurance and compliance responsibilities.
• Proven track record in leading regulatory strategies for the successful approval of gene therapy, gene editing, or RNA therapeutics products is strongly preferred. Experience with ophthalmology, neuroscience, and rare diseases is a plus.
• Demonstrated strong hands-on execution of regulatory strategies partnering with both internal and external key stakeholders.
• Proven track record of leading interactions with the US FDA, including successful IND, NDA, BLA submissions, advisory meetings, and ongoing regulatory compliance,, particularly in gene therapy, gene editing, RNA therapeutics, biologics, and advanced therapies and strong relationships with the agency is required, with additional experience in global regulatory environments and product approval preferred.
• Strong ability and proven track record managing cross-functional teams and projects.
• Demonstrated experience in leading quality systems and ensuring compliance with GMP, GCP, and GLP standards.
• Strong experience with regulatory inspections, audits, and CAPA processes.

Competencies:

• Uncompromising integrity with a commitment to maintaining the highest ethical standards in all regulatory, quality, and compliance activities.
• Strategic thinker with a results-oriented approach and the ability to navigate complex challenges in a start-up environment.
• Excellent strategic planning, problem-solving, and decision-making skills, with high attention to details.
• Excellent communication and interpersonal skills, with the ability to influence internal and external stakeholders, with strong negotiation and advocacy skills, and represent the company with regulatory authorities.
• Adaptability to evolving regulatory landscapes and quality standards.

• Entrepreneurial and passionate about innovative science and drug development, with strong resilience, agility and ability to manage ambiguity and make decisions with limited information and resources.
• A strong team player, contributing to the highly collaborative and fun culture.

Benefits:

We provide a vibrant startup environment where every employee contributes to our culture and science. We offer a generous total rewards plan that includes competitive compensation, stock options, and benefits. Our benefits include a top-tier health and wellness plan, commuter reimbursement or paid monthly parking, tuition or loan reimbursement, career development opportunities and so much more.

A final note - we highly encourage you to apply for our position, even if you are not sure you meet all the requirements. Everyone has unique talents, and at Ascidian, we look not only at your experience but your potential. We know that the best teams consist of diverse backgrounds, so please apply!