Retro develops therapies for diseases driven by the biology of aging. We focus on cellular reprogramming and autophagy to rejuvenate cell and tissue function with the ultimate aim of adding 10 years to healthy human lifespan.
We’re building a mission-driven team of accomplished and kind individuals who embrace our startup culture of rapid iteration, transparency, and versatility.
We are hiring someone to lead our regulatory efforts and help get Retro from pre-IND to first-in-human clinical trial. In this role, you’ll help oversee and advance the lifecycle of all of Retro’s therapeutics. You’ll act as the bridge between Retro’s internal research and future manufacturing and regulatory bodies, such as the FDA. You will report to the CEO and work closely with the team leads.
About You:
You’re fluidly intelligent - you understand the areas of research, manufacturing, and regulatory and can see how all the processes work together and what the key milestones are on the path to clinical stage Retro. You’re a stellar communicator and know how to adjust as needed to collaborate with internal teams, external consultants, and regulatory agencies. You are well-organized, proactive, and adept at multitasking and managing pipelines.
In this role you will:
- Lead, define, and manage the strategic regulatory direction for Retro's pipeline.
- Establish the regulatory pathway to IND filing for our programs.
- Provide strategic guidance and input related to current regulatory requirements and expectations for cell and gene therapy and small molecules CMC in support of clinical trial and marketing applications.
- Prepare content and provide regulatory input to key development documents, including clinical protocols, clinical and nonclinical reports and summary documents, statistical analysis plans, etc.
- Identify, communicate, and propose resolutions to routine and complex strategic issues.
- Drive workflows related to FDA and foreign regulatory agency interactions (ie, briefing documents and responses to questions).
- Interface with CMC, nonclinical research, and clinical research aspects of Retro’s programs and help keep stakeholders apprised of new regulations, standards, policies, and guidance issued by domestic and international regulatory authorities.
- Serve as a liaison between the company and regulatory agencies; serving as primary point of contact for agencies such as the FDA, EMA, TGA, and other global health authorities.
- Schedule and coordinate meetings (e.g. INTERACT, pre-IND) and oversee the development, compilation, and timely submission of all regulatory documentation to meet program timelines.
- Develop and coordinate high-quality submissions for clinical trials.
- Strategize, lead, write, and/or supervise the development and submission of documents or plans (e.g. Orphan, Breakthrough, Fast Track, Accelerated Approval) to regulatory agencies to support development goals.
You might thrive in this role if you have:
- At least 7 years of experience in a Regulatory capacity with experience in drug development
- At least 3 years of experience working with cell therapies in a regulatory capacity.
- Proven success advancing therapeutics from pre-IND to first-in-human clinical trial.
- Experience in supporting the development and implementation of complex regulatory strategies.
- Experience with clinical trial submissions in the US and proven track record with global regulatory agencies
- Experience in development, manufacturing, and testing of cell therapeutics is highly desired.
- Experience developing and documenting regulatory strategies in coordination with clinical plans and marketing objectives.
- Deep understanding of regulatory requirements in the US and EU for cell and gene therapy and small molecules drug products .
- Proven success interacting efficiently with Preclinical Research, CMC, and Clinical.
- The ability to continuously adapt in a dynamic environment with diverse teams and communication styles.
- Experience effectively communicating the regulatory strategy, issues, and risks in written and verbal format to senior leadership team and other governing bodies.
We take pride in cultivating an environment that fosters collaboration, open communication, and authenticity. We believe that great results are best delivered by a highly creative team working in concert. We are an equal opportunity employer; we do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. We are diverse in background and singular in mission.
