Aspen Neuroscience, as a leading iPSC platform company, combines stem cell biology with the latest artificial intelligence and genomic approaches to investigate patient-specific, restorative treatments. We are looking for a new addition to our Regulatory Affairs team. The Associate Director, Regulatory Affairs, CMC the development of regulatory CMC strategies to support early to late-stage clinical development and marketing registration of the company’s investigational product(s). is a hybrid position located in San Diego, CA. This role requires a high degree of on-site collaboration. At this time, we are not considering fully remote applicants.
DUTIES AND RESPONSIBILITIES:
- Proactively manage CMC aspects of one or more cell therapy and clinical delivery device development programs including overseeing preparation and submission of CMC submissions, including clinical trial applications (IND Module 3/IMPDs).
- Ensure that CMC content is complete, well-written, and meets all relevant requirements.
- Stay abreast of current and evolving regulatory CMC requirements for cell therapies and medical devices, applying this knowledge to assigned projects, and providing regulatory guidance to Quality, Manufacturing, Process Development, and other functional groups and stakeholders.
- Lead projects with cross-functional teams and act as the primary CMC contact with global health authorities for assigned products and projects.
- Contribute to the design, development, and implementation of product development strategies, regulatory risk management and contingency plans, and provide recommendations within the area of CMC regulatory expertise.
- Manage regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP/quality investigations throughout development.
- Manage interactions with FDA and other global regulatory authorities for assigned projects to ensure acceptance, rapid review and approval of original INDs, clinical trial applications, and other submissions which include CMC information.
- May perform other duties as assigned.
EDUCATION AND EXPERIENCE:
- Bachelor's degree with a minimum of 6 years’ relevant experience in regulatory affairs, or a master’s degree/doctorate with a minimum of 4 years’ relevant experience in regulatory affairs strongly preferred.
- Degree in a life sciences discipline strongly preferred.
- Biologics experience required; cell or gene therapy experience strongly preferred. Medical device experience also preferred.
- Experience as a regulatory contributor for INDs required; experience as a regulatory contributor for BLA, NDA, MAA, and CTA filings in the US and Europe is preferred.
- Excellent interpersonal skills to communicate difficult concepts and persuade others.
- Strategic thinking and strong problem-solving skills with outstanding attention to detail.
- Collaborates and communicates in an open, clear, complete, timely, and consistent manner.
- Strong sense of planning and prioritization, and the ability to work with all levels of management.
- Advanced knowledge of regulations and regulatory guidelines (FDA, EMA, MHRA, Health Canada, and ICH).
- Sound knowledge of the biotechnology/biopharmaceutical industry, including the functions and roles involved in the product development process.
- Effective decision-making skills, with a track record of making good business decisions and exercising sound judgment. Consistently and effectively balances decisions with imperatives for ethics and effectiveness.
- Strong computer skills, including Microsoft Office Suite (Word, PowerPoint, and Excel) and Adobe Acrobat.