As part of our new Regulatory function, you will provide strategic CMC-regulatory leadership to influence the development of our innovative CAR T cell therapy product AIC100.
This role is based out of our Natick, Mass., headquarters on a hybrid basis. Remote candidates with a willingness to travel regularly to Natick, Mass., will be considered on a case-by-case basis.
DIRECTOR of CMC REGULATORY AFFAIRS
AffyImmune, a clinical stage biotechnology company focused on developing technologies that expand the utility and improve the safety and efficacy of cell-based immunotherapy for cancer, is seeking a Director of CMC Regulatory Affairs to help advance the use of CAR T therapy for solid tumors. In this role, you will join a small team at a dynamic startup. You will define and implement regulatory strategic with respect to CMC development, participate in cross-functional teams including the program team to drive clinical development and major regulatory submissions, and own negotiations with health authorities to initiate and deliver key regulatory documents.
CMC Regulatory Strategy (65%)
- Serve as primary thought partner to CMC organization with respect to regulatory advice for CMC regulatory submissions.
- Develop and implement the program’s domestic and global CMC regulatory strategy, ensuring it is crafted to deliver rapid approval with competitive labelling that is identified by the business, markets, and patients.
- Develop and maintain health authority engagement strategy, interaction plan, and calendar, driving the formulation of briefing documents focused on strategic and scientific content.
- Lead the Program Team representatives who will engage with health authorities through meeting rehearsals for CMC regulatory milestones. Develop talking points, moderate the meetings, and lead the “command center” for time-sensitive responses to CMC regulatory submissions.
- Proactively identify and communicate risks and propose solutions to complex regulatory CMC issues.
- Interpret global regulations and guidance to identify regulatory opportunities and risks to AffyImmune’s cell-based gene therapy portfolio.
- Evaluate technical change proposals and develop effective implementation strategies as appropriate.
Business Operations Support – Regulatory (35%)
- Lead cross-functional regulatory efforts for CMC regulatory submissions.
- Liaise with the Quality team to ensure compliance with SOPs with respect to CMC regulatory submissions.
- Perform gap assessment for existing CMC regulatory process and control, identifying and implementing remediations as needed.
Qualifications:
- Bachelor’s degree in engineering, life sciences or related fields with 7-10 years Regulatory Affairs experience in a pharma/biotech environment.
- Experience with cell and gene therapy modalities (e.g. viral vectors, autologous cell therapies, plasmids) is required and work in small biotech/startup environments a plus.
- Track record of CMC regulatory drug development, including material involvement in key interactions with health authorities. Demonstrated experience with IND, IND-A, and BLA filings required.
- Experience working with multidisciplinary teams required.
- Prior experience representing regulatory affairs at the functional and core/program level required.
- Meticulous attention to detail, including capacity to conduct thorough self-reviews.
- Strategic thinker with the ability to interpret, summarize, and present problems and discern criticality of issues for escalation. Excellent written and verbal communication skills required.
- Strong work ethic, enthusiasm, eagerness to learn, bias for action, and willingness to perform ad-hoc tasks.
- Highly organized, collaborative, and motivated in a fast-paced startup environment.
- Comfort with Microsoft Office (PowerPoint, Excel, Word, OneDrive) and electronic document management systems (Veeva, e.g.).
This is a salaried, benefits-eligible position. Remote candidates can expect to travel to Natick, Mass., headquarters at least one week per month.
