As the leader of our new Regulatory function, you will define and implement regulatory strategy with respect to product development and own negotiations with health authorities to deliver key regulatory documents.
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.
VICE PRESIDENT of 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 Vice President Regulatory Affairs to help advance the use of CAR T therapy for solid tumors. Reporting to the Chief Executive Officer, you will join a small team at a dynamic startup. As part of the Leadership team, you will provide strategic regulatory leadership to influence the development of our innovative CAR T cell therapy product AIC100. You will participate in cross-functional and leadership teams including the program team to drive product development and major regulatory submissions.
Regulatory Strategy (80%)
- Build and drive Regulatory function by providing expert strategic insights toward product approvals.
- Develop and implement the program’s domestic and global clinical 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 clinical regulatory milestones. Develop talking points, moderate the meetings, and lead the “command center” for time-sensitive responses to clinical regulatory submissions.
- Perform gap assessment for existing clinical regulatory process and control, identifying and implementing remediations as needed.
- Develop and ensure Regulatory strategy alignment of pipeline programs with CMC, Clinical, and Nonclinical actives to meet Regulatory milestones.
Business Operations Support – Regulatory (20%)
- Lead cross-functional clinical regulatory submission efforts: NDA, BLA, IND, protocol amendments, Investigator’s Brochure updates, clinical trial site updates, and annual reports.
- Liaise with the Clinical Development Operations team to ensure regulatory document compliance for TMF.
- Liaise with the Quality team to ensure compliance with SOPs with respect to CMC regulatory submissions. Train on and execute against Regulatory Affairs duties dictated by existing SOPs.
- Other duties as assigned.
Qualifications:
- Advanced degree in life sciences with 12+ years Regulatory Affairs experience in a pharma/biotech environment. Experience with cell and gene therapy modalities (e.g. viral vectors, autologous cell therapies, plasmids) and in small biotech/startup environments a plus.
- Track record of clinical regulatory drug development, including leadership of key interactions with health authorities. Demonstrated experience with IND and BLA or NDA filings required.
- Experience working with multidisciplinary and executive teams required.
- Knowledge, understanding, and ability to apply guiding principles of drug development (benefit/risk, determination of recommended phase 2 dose, statistical design) 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 will travel to Natick HQ at least one week per month.
